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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pulse oximeter for over-the-counter use
Definition Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring
Product CodeOLK
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

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