Who is the manufacturer of Cloud9 System?

Insleep Technologies, LLC filed the 510(k) submission for Cloud9 System (K150365).

What is the FDA product code for Cloud9 System?

BZD. It is classified under 21 CFR 868.5905 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Cloud9 System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Cloud9 System?

AEIOMED Model 300157 CPAP System (now marketed by Somnetics as Transcend) (K100121); Resmed Swift Air (now marketed as AirFit P10) (K132013).

Who can help prepare an FDA 510(k) submission like Cloud9 System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cloud9 System

K150365 · Insleep Technologies, LLC · BZD · Jul 21, 2015 · Anesthesiology

Device Facts

Record ID	K150365
Device Name	Cloud9 System
Applicant	Insleep Technologies, LLC
Product Code	BZD · Anesthesiology
Decision Date	Jul 21, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5905
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The Cloud9® System is indicated for use by adults to reduce or eliminate simple snoring. The Cloud9® System maintains a continuous, positive low-pressure in the airway. The device is designed for prescription home use.

Device Story

Cloud9 System is a CPAP device for snoring reduction. It consists of an airflow unit (AFU) and a custom nasal mask (NiteCap). The device delivers continuous positive airway pressure at low levels (2-4 cmH2O). The blower is controlled by pressure measurements at the nasal interface to maintain constant pressure. It is intended for prescription home use by adults. The healthcare provider prescribes the device; the patient operates it at home. The output is a constant low-pressure airflow that stabilizes the airway to reduce snoring noise. This provides a non-invasive treatment option for simple snoring, potentially improving sleep quality for the user.

Clinical Evidence

Prospective, interventional study of 24 habitual simple snorers (subjects as own controls). Primary endpoint: reduction in snoring as % of sleep time. Results: 86% reduction in loud snoring and 67% reduction in all snoring (success criteria >50% reduction met). Secondary endpoint: reduction in nightly noise exposure below 45 dBA; loud snoring reduced from 34% to 5% of sleep time (success criteria >50% reduction met). No adverse events reported.

Technological Characteristics

CPAP blower system with custom nasal interface. Pressure range 2-4 cmH2O. Materials comply with ISO 10993-1. Connectivity: Standalone. Power: 100-240VAC. Standards: ISO 17510-1/2, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62366, IEC 62304, ISO 14971. Software: Firmware-based control of blower pressure via nasal interface feedback loop.

Indications for Use

Indicated for adults to reduce or eliminate simple snoring. Designed for prescription home use.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

AEIOMED Model 300157 CPAP System (now marketed by Somnetics as Transcend) (K100121)
Resmed Swift Air (now marketed as AirFit P10) (K132013)

Reference Devices

Invent (K120665)
DeVilbiss Intellipap (K071689)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-002 July 21, 2015 inSleep Technologies, LLC (inSleep Health) C/O Ms. Adrienne Lenz Senior Consultant, Quality Assurance and Regulatory Affairs Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Re: K150365 > Trade/Device Name: Cloud 9® System Regulation Number: 21 CFR 868.5905 Regulation Name: Non-Continuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: June 15, 2015 Received: June 22, 2015 Dear Ms. Lenz: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. *Tejashri Purohit-Sheth, M.D.* Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K150365 Device Name Cloud9® System Indications for Use (Describe) The Cloud9® System is indicated for use by adults to reduce or eliminate simple snoring. The Cloud9® System maintains a continuous, positive low-pressure in the airway. The device is designed for prescription home use. | Type of Use (Select one or both, as applicable): | | |---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------| | <div>✓ Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary for # Cloud9® System ### K150365 #### 1. Submission Sponsor inSleep Health 12100 Singletree Lane Suite 183 Eden Prairie, MN 55344 USA Phone: (952) 746-1324 Fax: (954) 888-9600 Contact: Marty Kerber, SVP, Engineering and Manufacturing #### 2. Submission Correspondent Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: PHONE Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Adrienne Lenz, Senior Consultant, Quality Assurance and Regulatory Affairs Email: project.management@emergogroup.com #### 3. Date Prepared June 12, 2015 #### 4. Device Identification | Trade/Proprietary Name: | Cloud9® System | |----------------------------|----------------------------------------------| | Common/Usual Name: | Continuous positive airway pressure (CPAP) | | Classification Name: | Noncontinuous ventilator (IPPB) | | Classification Regulation: | 868.5905 | | Product Code: | BZD, ventilator, non-continuous (respirator) | | Device Class: | Class II | | Classification Panel: | Anesthesiology | {4}------------------------------------------------ ### 5. Legally Marketed Predicate Device(s) Main Predicate K100121 AEIOMED Model 300157 CPAP System (now marketed by Somnetics as Transcend) K132013 Resmed Swift Air (now marketed as AirFit P10). ### 6. Device Description The Cloud9® System is a device for delivery of low levels of continuous positive airway pressure (CPAP) that can be used by people who wish to reduce or eliminate their snoring. lts main components include the airflow unit (AFU) and custom nasal mask interface, called the NiteCap™. The Cloud9® System delivers CPAP at low pressures ranging from 2 to 4 cmH₂O, via a nasal interface. The blower generating the airstream is controlled continuously based on pressure measurements at the nasal interface to maintain the pressure at the nose of the user constant ("CPAP"). Its performance is similar to currently used CPAP devices. ### 7. Indication for Use Statement The Cloud9® System is indicated for use by adults to reduce or eliminate simple snoring. The Cloud9 System maintains a continuous, positive low-pressure in the airway. The device is designed for prescription home use. ### 8. Substantial Equivalence Discussion The following table compares the Cloud9® System to the predicate devices with respect to indications for use, intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. | Manufacturer | inSleep Health | Somnetics (cleared by AEIOMED) | Resmed | SIGNIFICANT DIFFERENCES | |----------------------|------------------------------------|---------------------------------------------------------------|----------------------------------------------|----------------------------| | Trade Name | Cloud9® System | Model 300157 CPAP System (now marketed as Transcend) | Swift Air (now marketed as AirFit P10) | | | 510(k) Number | This submission | K100121 | K132013 | None | | Product Code | BZD | BZD | BZD | None | | Regulation Number | 868.5905 | 868.5905 | 868.5905 | None | | Regulation Name | Noncontinuous ventilator (IPPB) | Noncontinuous ventilator (IPPB) | Noncontinuous ventilator (IPPB) | None | | Table 5A – Comparison of Characteristics | | |------------------------------------------|--| |------------------------------------------|--| {5}------------------------------------------------ | Manufacturer | inSleep Health | Somnetics (cleared by AEIOMED) | Resmed | SIGNIFICANT DIFFERENCES | |---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Cloud9® System | Model 300157 CPAP System (now marketed as Transcend) | Swift Air (now marketed as AirFit P10) | DIFFERENCES | | Indications for Use | The Cloud9® System is indicated for use by adults to reduce or eliminate simple snoring. The Cloud9® device maintains a continuous, positive low- pressure in the airway. The device is designed for prescription home use. | The Model 300157 CPAP System is a single patient reusable device. The Model 300157 CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with Obstructive Sleep Apnea. | The Swift Air channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device. The Swift Air is: * to be used by patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed * intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutiona l environment. | The Cloud9® System's indication is similar to the Invent (K120665) which provides expiratory positive airway pressure to reduce or eliminate snoring. | | Mechanism of Action | Continuous Positive Airway Pressure (CPAP) | Continuous Positive Airway Pressure (CPAP) | Continuous Positive Airway Pressure (CPAP) or BiLevel Positive Airway Pressure (BiPAP) | None | | Technology | Blower Nasal mask held in place with adjustable headgear that straps the mask to the face. | Blower Nasal mask held in place with adjustable headgear that straps the mask to the face. | Nasal mask held in place with adjustable headgear that straps the mask to the face. | None | | Manufacturer | inSleep Health | Somnetics (cleared by AEIOMED) | Resmed | SIGNIFICANT DIFFERENCES | | Trade Name | Cloud9® System | Model 300157 CPAP System (now marketed as Transcend) | Swift Air (now marketed as AirFit P10) | | | CPAP Type | User adjustable fixed CPAP pressure | Auto CPAP | NA - channels airflow noninvasively to a patient from a PAP device such as a CPAP or bilevel device. | A prescribed pressure is not required for this indication and therefore users can select the pressure that works best to reduce or eliminate their snoring. | | Patient Circuit Connection | Custom connector (15 mm ID) that includes the measurement lumen in one single connector | Air outlet connector port: 19-mm diameter proprietary connector Universal Adapter Port Dimensions 22- mm diameter connector | Conical connectors (ref. ISO 5356- 1:2004). | The Cloud9®System's circuit includes a second small lumen to measure pressure at the nose and a custom connector prevents patients from using another, not approved circuit with the Air Flow Unit. | | Pressure Range | 2 to 4 cm H2O | 4 to 20 cm H2O | 4 to 20 cm H2O | Lower maximum pressure (4 cm H2O) for the treatment of snoring. Other CPAP devices, such as DeVilbiss Intellipap (K071689) also use lower pressures, down to 3 cmH2O. | | Pressure Stability (cmH2O) as measured by ISO 17510-1 | Less than +/-1 cm H2O at all pressure levels | Not specified | Not applicable to interface | Cloud9 meets requirements of ISO 17510-1 like other CPAP devices. | | Manufacturer | inSleep Health | Somnetics (cleared by AEIOMED) | Resmed | SIGNIFICANT DIFFERENCES | | Trade Name | Cloud9® System | Model 300157 CPAP System (now marketed as Transcend) | Swift Air (now marketed as AirFit P10) | | | Maximum Flow (LPM) | 71 L/min for all pressure settings | 71 L/min at 4cmH₂O, 75 L/min at 8cmH₂O | Not applicable to interface | Cloud9 meets requirements of ISO 17510-1 like other CPAP devices. | | Maximum System Shutdown Pressure | 30 cm H₂O | 30 cm H₂O | Not applicable to interface | None | | Mask Sizes | InSleep nasal interface (the Butterfly) is available in Small, Medium, Large and Extra Large (S, M, L & XL) | K100121 includes a patient interface, but details are not publically available. | AirFit P10 XS, S,M, L AirFit P10 for Her XS, S, M,L | Both are available in various sizes to fit different users. | | Mask Dead space | Less than 52 ml | Seal dead space Less than 301 cc | Large pillows 123 mL. | The Cloud9® System dead space is lower and thus better than the predicate device | | Resistance/ Drop in pressure as measured according to 17510-2 | at 50 L/min: 5.7 cm H₂O at 100 L/min: 21.1 cm H₂O | At 50 l/min 0.140 cm H₂O At 100 l/min 0.278 cm H₂O | at 50 L/min: 0.4 cm H₂O at 100 L/min: 1.4 cm H₂O | The Cloud9® System is working with smaller hoses which increases the resistance. The Cloud9® mask and interface can therefore only be used with the Cloud9® AFU, that is specifically designed to work with the higher resistance mask. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ | Manufacturer | inSleep Health | Somnetics (cleared by AEIOMED) | Resmed | SIGNIFICANT DIFFERENCES | |--------------|----------------------------|---------------------------------------------------------------|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Cloud9® System | Model 300157 CPAP System (now marketed as Transcend) | Swift Air (now marketed as AirFit P10) | | | AC Powered | 100 – 240VAC 50-60hz | Input 100-240 VAC, 50- 60Hz Output 19VDC, 2.6 Amp | Not applicable to interface | The Cloud9® System meets the same standards for electrical safety and electromagnetic compatibility as its predicate devices. | | Materials | Comply with ISO 10993-1 | Comply with ISO 10993-1 | Comply with ISO 10993-1 | None | #### 9. Non-Clinical Performance Data As part of demonstrating safety and effectiveness of Cloud9® System and in showing substantial equivalence to the predicate devices, inSleep Health completed a risk analysis and a number of tests. The Cloud9® System meets all the requirements for overall design, cleaning, biocompatibility, electrical safety and software and test results confirm that the output meets the design inputs and specifications. The Cloud9® System passed all testing as shown by the acceptable results obtained. The Cloud9® System complies with the applicable voluntary standards for biocompatibility, electrical safety, usability and CPAP performance. The device passed all the testing in accordance with the following international standards. - ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part 1: Evaluation and . Testing - IEC 60601-1: 2005, Medical Electrical Equipment - Part 1: General Requirements for Safety - IEC 60601-1-2: 2007. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests - IEC 60601-1-11:2010, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment - ISO 17510-2: 2007: Sleep apnoea breathing therapy -Part 2: Masks and application accessories - . ISO 17510-1: 2007: Sleep Apnoea Breathing Therapy. Part 1: Sleep Apnoea Breathing Therapy Equipment. - IEC 62366: 2007 Medical devices - Application of usability engineering to medical devices {9}------------------------------------------------ - IEC 60601-1-6: 2010 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance -- Collateral Standard: Usability - . IEC 62304: 2006, Medical device software - Software life cycle processes - . ISO 14971: 2007, Medical devices -- Application of risk management to medical devices Table 5B summarizes the biocompatibility testing performed. | Part Name | Contact Type/Duration | Tests Conducted | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Air Circuit | Skin - Permanent duration (>30 days) based on cumulative contact every night. AND Airway gas - humidified due to patient exhalation (considered external communication with tissue) permanent duration (>30 days) based on cumulative contact every night | • Cytotoxicity • Sensitization • Irritation/intracutaneous reactivity • System toxicity (acute) • Pyrogenicity (as part of Systemic toxicity) • Subchronic toxicity (subacute toxicity) • Genotoxicity • Implantation • Chemical Characterization (identification of extractable compounds) | | Main Hose | Skin - Permanent duration (>30 days) based on cumulative contact every night. AND Airway gas - dry. | • Cytotoxicity • Sensitization • Irritation/intracutaneous reactivity • Chemical Characterization (identification of particulates and VOCs) | | Air flow unit internal components | Airway gas - dry. No direct patient contact | • Chemical Characterization (identification of particulates and VOCs) | | NiteCap™ Fit System - Sport / Athletic | Skin - Permanent duration (>30 days) based on cumulative contact every night. | • Cytotoxicity • Sensitization • Irritation/intracutaneous reactivity | | | Table 5B - Biocompatibility Testing | | |--|-------------------------------------|--| |--|-------------------------------------|--| Additional verification and validation testing included: - Validation of cleaning methods . - . Validation to demonstrate that all features of the Cloud9 System were compliant with the system, software and firmware level requirements. - Testing of the usability of the Cloud9 System to evaluate the ability of an adult to unpack, assemble, operate and disassemble the Cloud9® System safely and effectively. {10}------------------------------------------------ - Environmental testing to evaluate the use of Cloud9's Air Flow Unit in a variety of environmental conditions. - . Testing to determine the 6-month recommended change interval for the Cloud9® System's Filter Assembly. - Verification that the cleaning methods do not affect device performance over the ● claimed lifetime or replacement intervals - Verification of the maximum pressure under single fault conditions - . Verification of the maximum temperature at the patient connection port under normal and single fault conditions # 10. Clinical Performance Data A clinical study was conducted to evaluate safety and efficacy of the Cloud9® System to reduce or eliminate simple snoring. The study was a prospective, interventional study of habitual simple snorers with subjects serving as their own controls. The overall design involved four subject visits as follows: - 1. Baseline assessment of snoring and sleep parameters by PSG - 2. Titration study to determine the lowest effective level of CPAP within the range of 2 to 6 cm H₂O - Full treatment night at the previously determined CPAP level (Visit 2) 3. - 4. Second control night off CPAP to assess and change from baseline over the course of the trial. Device safety was assessed by the occurrence of adverse events (nasal or skin irritation, epistaxis and sleep disruption) noted during device use (Visits 2 and 3). A total of 24 subjects were evaluated at three centers. Table 5C presents the study endpoints, results and conclusions. {11}------------------------------------------------ | | . | | |----------------------------|-------------------------------|------------------------------| | Study Endpoint | Result | Conclusion | | Primary - Reduction in | There was an average of 86% | The Cloud9 System is | | the number of all snores | reduction in loud snoring and | effective for its indication | | or reduction in loud | 67% reduction in all snoring | to reduce or eliminate | | snores as percent of sleep | | simple snoring. The | | time with the device | | primary endpoint was met | | (Visits #2 and #3). | | with a greater than 50% | | Success criteria: 50% | | reduction in all snores. | | reduction in all snores OR | | | | at least a 90% reduction | | | | in loud snores as a | | | | percent of sleep time | | | | Secondary - Reduction in | Loud snoring was reduced | The Cloud9 System is | | overall nightly noise | from 34% of sleep time to 5% | effective for its indication | | exposure below the WHO | of sleep time with the | to reduce or eliminate | | limit of 45 dBA. | Cloud9™ and the total time | simple snoring. The | | Success criteria: 50% | spent in loud snoring was | secondary endpoint was | | reduction in snoring time | reduced from 148 minutes to | met with a greater than | | > 45 dBA | 18 minutes, a greater than | 50% reduction in snoring | | | 50% reduction. | time ≥ 45 dBA (loud | | | | snoring). | | Safety — No adverse | No adverse events occurred | The safety endpoint was | | events (nasal or skin | during this study. | met. | | irritation, epistaxis and | | | | sleep disruption) noted | | | Table 5C – Study Results and Conclusions ### 11. Statement of Substantial Equivalence It has been shown in this 510(k) submission that the difference between the Cloud9® System and the predicate devices do not raise any questions regarding its safety and effectiveness. The Cloud9® System, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

Cloud9 System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Cloud9 System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps