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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeQOK
Regulation Number 870.2786
Device Class 2


Premarket Reviews
ManufacturerDecision
CONTINUSE BIOMETRICS LTD.
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