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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device infant pulse rate and oxygen saturation monitor for over-the-counter use
Definition An infant pulse rate and oxygen saturation monitor for over-the-counter use is a device that uses photoplethysmography to measure pulse rate and oxygen saturation in infants. The device may contain alarms that alert the caregiver when vital sign(s) go outside preset threshold(s).
Product CodeQYU
Regulation Number 870.2705
Device Class 2


Premarket Reviews
ManufacturerDecision
OWLET BABY CARE, INC.
  GRANTED 1

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