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Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use

FDA product code QYU · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2705
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-05-03 – 2024-05-03

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).

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