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U.S. Department of Health and Human Services

Product Classification
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Device hardware and software for optical camera-based measurement of heart rate and respiratory rate
Regulation Description Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
Definition The device uses an optical sensor system and software algorithms to obtain and analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.
Physical State Optical system consisting of a sensing unit and a mobile unit
Technical Method Uses an image sensor to capture the back-reflected light pattern from an illuminated subject
Target Area Chest
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQOK
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.2786
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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