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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeQME
Regulation Number 870.2785
Device Class 2


Premarket Reviews
ManufacturerDecision
FACEHEART CORP.
  SUBSTANTIALLY EQUIVALENT 1
MINDSET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
NURALOGIX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OXEHEALTH LIMITED
  SUBSTANTIALLY EQUIVALENT 4
  GRANTED 1
PANOPTICAI TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 2
PRESAGE SECURITY, INC. D/B/A PRESAGE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
QOMPIUM NV
  SUBSTANTIALLY EQUIVALENT 1

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