← Product Code [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN) · K051565 # PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA (K051565) _Proton Healthcare , Ltd. · DXN · Sep 12, 2005 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K051565 ## Device Facts - **Applicant:** Proton Healthcare , Ltd. - **Product Code:** [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN.md) - **Decision Date:** Sep 12, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1130 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use All five models automatically measures human's Systolic, Diastolic blood pressure and pulse rate by using the oscillometric method. The measurement results are displayed in one LCD Panel. The intended use of Models PH168A, PH168E and PH168W is for age 16 and above. The intended use for the Models PHC888JA and PH888HA is for adult patients whose arm circumference is between 24-32cm (approx. 8.7" to 12.6"). ## Device Story Digital blood pressure monitors (Models PH168A, PH168E, PH168W, PHC888JA, PH888HA) utilize oscillometric method to measure systolic/diastolic blood pressure and pulse rate. Device inputs include pressure oscillations detected via cuff; internal processor calculates blood pressure values; output displayed on integrated LCD panel. Intended for over-the-counter use by patients for self-monitoring. Provides non-invasive hemodynamic data to assist users in tracking blood pressure trends. ## Clinical Evidence No clinical data provided; substantial equivalence based on technological characteristics and intended use. ## Technological Characteristics Noninvasive oscillometric blood pressure measurement system. Digital display (LCD). Battery-powered. Models PHC888JA and PH888HA include specific cuff size constraints (24-32cm). ## Regulatory Identification A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body. ## 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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. SEP 1 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Proton Health Care Ltd. c/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight Inc. 13 Red Fox Lane Littleton, CO 80127 ## Re: K051565 No1200 Trade Name: Proton Digital Blood Pressure Monitor Models PH168A, PH168W, ade Name: Trees and Proton Blood Pressure Monitor Model PHC888JA Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 31, 2005 Received: September 1, 2005 Dear Mr. Walls: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to comments provision to May 20, 1976, the excordance with the provisions of the Federal Food, DNIg, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). allo Cosmetic Act (Act) that do not require app to the general controls provisions of the Act. The I ou may, merciole, market the act include requirements for annual registration, listing of general controls provision 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 If your device is crassified (see above) this. Existing major regulations affecting your device can thay be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Coursements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Mr. Kevin Walls, RAC 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 (QS) 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 (240) 276-0295. 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/industry/support/index.html. Sincerely yours, Bismimar for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Indications for Use 510(k) Number (if known): Kul S-15-6 ك Device Names: - 1. Proton Digital Blood Pressure Monitor, Model PH168A - Proton Digital Blood Pressure Monitor, Model PH168E 2. - Proton Digital Blood Pressure Monitor, Model PH168W က - 4. Proton Blood Pressure Monitor, Model PHC888JA - Proton Digital Blood Pressure Monitor, Model PH888HA 5. Indications for Use: All five models automatically measures human's Systolic, Diastolic blood pressure and All five models adtomatically measures haman's Cyclers, and out in one LCD Panel. The intended use of Models PH168A, PH168E and PH168W is for age 16 and above. The intended use for the Models PHC888JA and PH888HA is for adult patients whose The Interioed ass for the ween 24-32cm (approx. 8.7" to 12.6"). . Over-The-Counter Use _ × Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) B. Hemmer (Division Sign-Off) Division of Cardlovascular Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________ Page ( of l 、 , l --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K051565](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K051565) **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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