← Product Code [FLL](/productcode/FLL) · K031907 # NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551 (K031907) _Norm Pacific Automation Corp. · FLL · Aug 21, 2003 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K031907 ## Device Facts - **Applicant:** Norm Pacific Automation Corp. - **Product Code:** [FLL](/productcode/FLL.md) - **Decision Date:** Aug 21, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.2910 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Pediatric ## Indications for Use For intermittent measurement of body temperature in patient of all ages in home environment. The device is reusable and intended for oral, axillary or rectal temperature measurements. ## Device Story NPaC Digital Thermometer (Models ET300, ET303, ET350, ET351, ET400, ET403, ET450, ET451, ET500, ET503, ET550, ET551) measures body temperature; intended for home use by patients or caregivers. Device utilizes electronic sensor to detect temperature; displays result on integrated screen. Reusable design supports oral, axillary, or rectal measurement sites. Provides intermittent monitoring to assist in health assessment. ## Clinical Evidence No clinical data provided; substantial equivalence established via bench testing and comparison to existing legally marketed devices. ## Technological Characteristics Clinical electronic thermometer; electronic temperature sensing; battery-powered; digital display; reusable; intended for oral, axillary, or rectal use. ## Regulatory Identification A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover. ## Special Controls (1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads. AUG 2 1 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Norm Pacific Automation Corporation C/O Mr. Chi-Chu Wu Chen Regulatory Consultant New Century Technology 3F, No.31, Hu-Pin Road #1 Science Base Industrial Park Hsin-Chu, Taiwan, R.O.C. (300) Re: K031907 Trade/Device Name: NPaC Digital Thermometer Models ET300, ET303, ET350, ET351 ET400, ET403, ET450, ET451 ET500, ET503, ET550, ET551 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 17, 2003 Received: June 20, 2003 Dear Mr. Wu Chen: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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}------------------------------------------------ Page 2 - Mr. Wu Chen 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Suen Runner Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 3.0 INDICATIONS FOR USE STATEMENT 510(k) Number (if know) > Device Name: NPaC Digital Thermometer Models ET 300, ET 303, ET 350, ET 351 ET 400, ET 403, ET 450, ET 451 ET 500, ET 503, ET 550, ET 551 Indications for Use: For intermittent measurement of body temperature in patient of all ages in home environment. The device is reusable and intended for oral, axillary or rectal temperature measurements. PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Or Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use ## Silvano Lucenti Infortion Control De 510(k) Number: K031907 --- **Source:** [https://fda-staging.innolitics.com/device/K031907](https://fda-staging.innolitics.com/device/K031907) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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