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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
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OWLET BABYCARE, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2024 1 1
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Superficial (First Degree) Burn 1 1
Abrasion 1 1
Insufficient Information 1 1
Laceration(s) 1 1
Partial thickness (Second Degree) Burn 1 1
Low Oxygen Saturation 1 1

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