FDA product code QWE

Hyperoxia Monitoring Device Adjunct To Pulse Oximetry

Anesthesiology·Class 2·21 CFR 870.2720
US regulatory classifications
US Product Code (FDA)
QWE
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.2720
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Medical specialty
Anesthesiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Hyperoxia Monitoring Device Adjunct To Pulse Oximetry is a medical device type in the Anesthesiology 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.