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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device loss of pulse notification software
Regulation Description Photoplethysmograph analysis software for over-the-counter use.
Definition A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying loss of pulse. This device is not intended to provide a diagnosis.
Product CodeSDY
Regulation Number 870.2790
Device Class 2


Premarket Reviews
ManufacturerDecision
FITBIT
  SUBSTANTIALLY EQUIVALENT 1

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