FDA product code QYU

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

Cardiovascular·Class 2·21 CFR 870.2705
US regulatory classifications
US Product Code (FDA)
QYU
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.2705
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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).

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About this record

Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.