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U.S. Department of Health and Human Services

Product Classification
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Device software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate
Regulation Description Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
Definition The device uses software algorithms to 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 Software
Technical Method The device applies algorithms to video signal in order to identify pixel-level changes that correlate with pulse and breathing rates.
Target Area Human body
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQME
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.2785
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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