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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hyperoxia monitoring device adjunct to pulse oximetry
Definition A hyperoxia monitoring device adjunct to pulse oximetry is a device that monitors elevated hemoglobin oxygen saturation levels as an adjunct to arterial oxygen saturation monitoring.
Product CodeQWE
Regulation Number 870.2720
Device Class 2


Premarket Reviews
ManufacturerDecision
MASIMO CORPORATION
  GRANTED 1

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