Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)

{0} **FDA U.S. FOOD & DRUG** ADMINISTRATION September 18, 2026 Shenzhen Mericonn Technology Co., Ltd. % Jie Yang Consultant Chonconn Consulting Co., Ltd. Rm. 504, Block C, # 1029 Nanhai Ave., Nanshan District Shenzhen, Guangdong 518067 China Re: K254171 Trade/Device Name: Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: September 15, 2026 Received: September 15, 2026 Dear Jie Yang: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254171 - Jie Yang Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K254171 - Jie Yang Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, REBEKAH A. KELLY -S Digitally signed by REBEKAH A. KELLY -S Date: 2026.09.18 07:41:51 -04'00' for Ethan Nyberg Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254171 | ? | | Please provide the device trade name(s). | | ? | | Mesh Nebulizer (UN204);Mesh Nebulizer (UN205);Mesh Nebulizer (UN209);Mesh Nebulizer (UN210) | | | | Please provide your Indications for Use below. | | ? | | The mesh nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.It is not intended for use with Pentamidine. | | | | Please select the types of uses (select one or both, as applicable). | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} # 510(k) ## Summary 1 / 10 {5} # 510(K) Summary Prepared in accordance with the requirements of 21 CFR Part 807.92 Prepared Date: September 15, 2026 ## 1. Submission sponsor Name: Shenzhen Mericonn Technology Co., Ltd. Address:3/F, Building 2, Tiantong Industrial Park, Gaofeng Community, Dalang Street, Longhua district, Shenzhen, Guangdong, P.R. China. Contact person: Jiang Chuanyuan Title: General Manager E-mail: karen@mericonn.com Tel: +86-755- 82580465 ## 2. Submission correspondent Name: Chonconn Consulting Co., Ltd. Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China 518067 Contact person: Yang Jie E-mail: yangjie@chonconn.com Tel: +86-755 33941160 ## 3. Subject Device Information | Trade/Device Name | Mesh Nebulizer | | --- | --- | | Model | UN204, UN205, UN209, UN210 | | Common Name | Mesh Nebulizer | | Regulatory Class | Class II | | Classification | 21CFR §868.5630 / Nebulizer | | Submission type | Traditional 510(K) | ## 4. Predicate Device | Device name and model | K number | Manufacturer | | --- | --- | --- | | Portable (Ultrasonic) Nebulizer Model NBM-1 | K230379 | Dongguan SIMZO Electronic Technology Co.Ltd. | ## 5. Device Description The mesh nebulizer is small, handheld, internally powered general purpose nebulizer which utilizes ultrasound vibrating mesh technology to generate aerosol. The device is intended to aerosolize liquid medications for inhalation therapy. The mesh nebulizer is made up of a main unit, a medicine cup, an adult mask, and a child mask. 2 / 10 {6} The four models of the mesh nebulizer, including UN204, UN205, UN209, and UN210, have the same working principle, specifications, structure, intended use and software. The only difference is the appearance and power supply configuration. UN204 and UN209 are powered by an internal Lithium battery that is charged via an AC adapter, while UN205 and UN210 are powered by two "AA" batteries or directly via an AC adapter. ## 6. Indications for use The mesh nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities. It is not intended for use with Pentamidine. ## 7. Comparison to the Predicate Device | ITEM | Proposed Device Mesh Nebulizer UN204, UN205, UN209, UN210 K254171 | Predicate Device Portable (Ultrasonic) nebulizer Model NBM-1 K230379 | Comparison Result | | --- | --- | --- | --- | | Manufacture | Shenzhen Mericonn Technology Co., Ltd. | Dongguan SIMZO Electronic Technology Co. Ltd. | / | | Indications for Use | The mesh nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities. | The ultrasonic nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities. | Substantially Equivalent | 3 / 10 {7} | | It is not intended for use with Pentamidine. | It is not intended for use with Pentamidine. | | | --- | --- | --- | --- | | Principle of operation | Vibrating mesh | Vibrating mesh | Substantially Equivalent | | Ultrasonic Oscillation Frequency | 110kHz±10% | 110 kHz ± 10KHz | Substantially Equivalent | | Aerosolization | Continuous during inhalation and exhalation | Continuous during inhalation and exhalation | Substantially Equivalent | | Compressed gas source | None needed | None needed | Substantially Equivalent | | Medicine Capacity | 10mL | 6 ml | Substantially Equivalent, see note 1 | | Nebulization rate | ≥0.2mL/min | >0.2mL/min | Substantially Equivalent | | Aerosol Performance | Table: Comparative particle test comparison | Table: Comparative particle test comparison | Substantially Equivalent, see note 2 | | Duration of Use | Single patient, multi-use | Single patient, multi-use | Substantially Equivalent | | Power supply | UN205/UN210: 1.5V*2AA Size Alkaline battery or d.c.5V/1A UN204/UN209: d.c.3.7V Lithium battery or d.c.5V/1A | DC3.0V, 2×AA batteries | Substantially Equivalent, see note 3 | | Waterproof | IP22 | IP22 | Substantially Equivalent | | Degree of protect on against electric shock | Type BF applied part | Type BF applied part | Substantially Equivalent | 4 / 10 {8} | Type of protection against electric shock | Internally power equipment | Internally power equipment | Substantially Equivalent | | --- | --- | --- | --- | | Model of operation | Continuous operation | Continuous operation | Substantially Equivalent | | Power off | On/Off button | On/Off button | Substantially Equivalent | | Operation environment | +5° C~+40° C ≤85%RH(Non-condensing) | 10 -40 , 10%-95%RH | Substantially Equivalent, see note 4 | | Storage environment | -20° C~+55° C ≤93%RH(Non-condensing) | -20°C to 70°C, 10%-95% RH | Substantially Equivalent, see note 4 | | Patient Connector | masks | Mouthpiece or masks | Substantially Equivalent | | Biocompatibility | All the patient contacting materials are compliance with ISO 10993 | All the patient contacting materials are compliance with ISO 10993 | Substantially Equivalent | | Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-1-11 | Compliance with IEC 60601-1 and IEC 60601-1-11 | Substantially Equivalent | | EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Substantially Equivalent | | Dimensions(mm) | UN204/UN205: 48(L)*49.6(W)*116.4(H)mm UN209/UN210: Approx50(L)*51(W)*115.3(H)mm | 60mm 55mm 130mm | Substantially Equivalent, see note 5 | | Weight (g) | UN204 Approx 92g UN205 Approx82g(without battery) UN209 Approx 98 g UN210 Approx 89g(without battery) | Approx.110g | Substantially Equivalent, see note 5 | 5 / 10 {9} Table: Comparative particle test comparison Adult condition | Features | Drug | Subject device- Mericonn Mesh Nebulizer, Model UN204 | Predicate device(K230379)- Simzo Portable(Ultrasonic) Nebulizer, Model NBM-1 | | --- | --- | --- | --- | | | | Adult mask | Adult mask | | Particle Size (MMAD) (microns) | albuterol sulfate (2.5 mg/3 ml) | \( 3.42 \pm 0.11 \) | \( 2.97 \pm 0.12 \) | | | ipratropium bromide (0.5 mg/ 2.5 ml) | \( 3.37 \pm 0.11 \) | \( 2.93 \pm 0.15 \) | | | cromolyn sodium (20 mg/2 ml) | \( 3.38 \pm 0.12 \) | \( 2.97 \pm 0.15 \) | | Geometric Standard Deviation | albuterol sulfate (2.5 mg/3 ml) | \( 1.70 \pm 0.13 \) | \( 2.20 \pm 0.26 \) | | | ipratropium bromide (0.5 mg/ 2.5 ml) | \( 1.83 \pm 0.11 \) | \( 2.20 \pm 0.20 \) | | | cromolyn sodium (20 mg/2 ml) | \( 1.77 \pm 0.09 \) | \( 2.17 \pm 0.06 \) | | Total Dose Delivered by Device (ug) | albuterol sulfate (2.5 mg/3 ml) | \( 1895.2 \pm 247.4 \) | \( 1922.4 \pm 243.4 \) | | | ipratropium bromide (0.5 mg/ 2.5 ml) | \( 349.3 \pm 49.6 \) | \( 358.2 \pm 38.7 \) | | | cromolyn sodium (20 mg/2 ml) | \( 14225.2 \pm 2075.4 \) | \( 13814.9 \pm 1779.6 \) | | Total Respirable Dose (0.5-5 um) (ug) | albuterol sulfate (2.5 mg/3 ml) | \( 1057.5 \pm 160.6 \) | \( 991.6 \pm 132.9 \) | | | ipratropium bromide (0.5 mg/ 2.5 ml) | \( 196.3 \pm 32.1 \) | \( 188.6 \pm 21.4 \) | | | cromolyn sodium (20 mg/2 ml) | \( 8132.1 \pm 1096.1 \) | \( 7573.4 \pm 1344.8 \) | | Coarse Particle Dose (>4.7 um) (ug) | albuterol sulfate (2.5 mg/3 ml) | \( 761.1 \pm 84.5 \) | \( 812.2 \pm 105.0 \) | | | ipratropium bromide (0.5 mg/ 2.5 ml) | \( 138.8 \pm 18.7 \) | \( 148.3 \pm 17.7 \) | | | cromolyn sodium (20 mg/2 ml) | \( 5514.9 \pm 964.0 \) | \( 5432.5 \pm 395.7 \) | | Fine Particle Dose (<4.7 um) (ug) | albuterol sulfate (2.5 mg/3 ml) | \( 1134.1 \pm 170.5 \) | \( 1109.5 \pm 138.7 \) | | | ipratropium bromide (0.5 mg/ 2.5 ml) | \( 210.5 \pm 32.0 \) | \( 209.9 \pm 21.0 \) | | | cromolyn sodium (20 mg/2 ml) | \( 8710.2 \pm 1167.0 \) | \( 8382.4 \pm 1397.1 \) | | Ultra-Fine Particle Dose (<1.0 um) (ug) | albuterol sulfate (2.5 mg/3 ml) | \( 223.6 \pm 34.3 \) | \( 302.1 \pm 36.4 \) | | | ipratropium bromide (0.5 mg/ 2.5 ml) | \( 43.8 \pm 5.5 \) | \( 57.3 \pm 6.4 \) | 6 / 10 {10} | | cromolyn sodium (20 mg/2 ml) | 1771.0±274.5 | 2216.9±228.1 | | --- | --- | --- | --- | | Pediatric condition | | | | | Features | Drug | Subject device- Mericonn Mesh Nebulizer, Model UN204 | Predicate device(K230379)- Simzo Portable(Ultrasonic) Nebulizer, Model NBM-1 | | | | child mask | child mask | | Particle Size (MMAD) (microns) | albuterol sulfate (2.5 mg/3 ml) | 4.00±0.37 | 4.13±0.23 | | | ipratropium bromide (0.5 mg/ 2.5 ml) | 3.79±0.30 | 3.93±0.15 | | | cromolyn sodium (20 mg/2 ml) | 3.56±0.17 | 3.70±0.35 | | Geometric Standard Deviation | albuterol sulfate (2.5 mg/3 ml) | 2.47±0.26 | 2.30±0.17 | | | ipratropium bromide (0.5 mg/ 2.5 ml) | 2.36±0.18 | 2.33±0.42 | | | cromolyn sodium (20 mg/2 ml) | 2.38±0.11 | 2.23±0.23 | | Total Dose Delivered by Device (ug) | albuterol sulfate (2.5 mg/3 ml) | 1911.0±179.0 | 1836.4±208.9 | | | ipratropium bromide (0.5 mg/ 2.5 ml) | 337.5±38.4 | 337.5±41.2 | | | cromolyn sodium (20 mg/2 ml) | 13948.4±1719.7 | 13339.4±1587.6 | | Total Respirable Dose (0.5-5 um) (ug) | albuterol sulfate (2.5 mg/3 ml) | 978.1±139.5 | 897.5±135.7 | | | ipratropium bromide (0.5 mg/ 2.5 ml) | 183.8±22.7 | 171.0±29.0 | | | cromolyn sodium (20 mg/2 ml) | 8098.5±1231.8 | 7444.0±1271.3 | | Coarse Particle Dose (>4.7 um) (ug) | albuterol sulfate (2.5 mg/3 ml) | 909.4±69.6 | 894.5±86.5 | | | ipratropium bromide (0.5 mg/ 2.5 ml) | 148.1±20.4 | 157.4±14.1 | | | cromolyn sodium (20 mg/2 ml) | 5634.0±589.9 | 5559.8±437.8 | | Fine Particle Dose (<4.7 um) (ug) | albuterol sulfate (2.5 mg/3 ml) | 1001.6±143.3 | 941.9±130.8 | | | ipratropium bromide (0.5 mg/ 2.5 ml) | 189.5±23.1 | 180.1±27.1 | | | cromolyn sodium (20 mg/2 ml) | 8314.4±1196.2 | 7779.6±1242.0 | | Ultra-Fine Particle Dose (<1.0 um) (ug) | albuterol sulfate (2.5 mg/3 ml) | 198.7±34.4 | 198.2±40.2 | | | ipratropium bromide (0.5 mg/ 2.5 ml) | 38.6±7.8 | 43.1±6.2 | 7 / 10 {11} | | cromolyn sodium (20 mg/2 ml) | 1687.5±294.5 | 1722.9±422.1 | | --- | --- | --- | --- | # **Note 1:** Medicine Capacity of the subject device is different from the predicate device. The subject device has been tested on safety and performance tests and the test results were complied with the test requests. The capacity variance represents a minor structural optimization that accommodates standard medication volumes and does not alter the core atomization mechanism. The difference does not raise new questions of safety and effectiveness when compared to the predicate device. # **Note 2:** From the Table: Comparative particle test comparison, all of the parameters were substantially equivalent to the predicate device. There were no statistically measurable differences between the subject device and predicate device, they are substantially equivalent. Please refer to page 14/32 of attachment Aerosol Performance Testing 24-0041 include datasheet for detailed analysis. The difference does not raise new questions of safety and effectiveness when compared to the predicate device. # **Note 3:** The power supply of subject device has one different type compared with predicate device, the subject device use AA battery or Lithium battery to supply power. The subject device has passed the test according to IEC 60601-1 and IEC 62133-2 standards. The difference does not raise new questions of safety and effectiveness when compared to the predicate device. # **Note 4:** The operation and storage environment of subject devices is different from the predicate device, and they are both in compliance with the IEC 60601-1-11 standard. The difference does not raise new questions of safety and effectiveness when compared to the predicate device. # **Note5:** The subject device has substantially equivalent specifications to the predicate device, such as dimensions and weight. Based on the nonclinical tests performed, those minor differences for specifications are fully validated. The difference does not raise new questions of safety and effectiveness when compared to the predicate device. 8 / 10 {12} ### 8. Non-Clinical and/or Clinical tests summary The following performance data were provided in support of the substantial equivalence determination. # **Electrical Safety and Electromagnetic Compatibility (EMC):** Electrical safety and EMC testing were conducted on the device. Testing established that, with respect to electrical safety, the device meets the applicable requirements of: - ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)] - IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEC TS 60601-4-2 Edition 1.0 2024-03 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems - IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 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 27427 Fourth edition 2023-07 Anaesthetic and respiratory equipment - Nebulizing systems and components - IEC 62133-2 Edition 1.1 2021-07 CONSOLIDATED VERSION Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems # **Safety and performance:** Particle characterization testing was performed on the subject device with both proposed patient interface and on the predicate per FDA guidance “Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators” (FDA/CDRH – 1993). # **Software Verification and Validation Testing** Software verification and validation testing were conducted, and documentation was provided as recommended by FDA’s Guidance for Industry and FDA Staff, “Content of Premarket Submissions for Device Software Functions”. # **Biocompatibility testing** According to FDA Guidance entitled, Use of International Standard ISO 10993-1, 9 / 10 {13} "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", the following biological compatibility test need to be executed as follow: In Vitro Cytotoxicity Test -ISO10993-5 Skin Sensitization Test -ISO10993-10 Intracutaneous Reactivity Test-ISO10993-23 Pyrogens Test -ISO 10993-11,USP<151> Biocompatibility evaluation- ISO 10993-1,ISO 18562-1 Chemical characterization study- ISO10993-18 Test for emissions of particulate matter - ISO 18562-2 Test for emissions of VOCs -ISO 18562-3 Toxicological risk assessment study-ISO10993-17 Under the parameters of the tests, it is concluded that they are biocompatible, and that there are no new issues of safety regarding their use as intended. ### Device life testing Device life were tested with simulation method; the device meets the applicable requirements. ### Clinical Testing Not applicable. ### 9. Conclusion Substantial equivalence comparisons, performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device. 10 / 10