Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
QWE · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 870.2720
Classification
FDA Product Code
QWE
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.2720
Review panel
AN
Medical specialty
Anesthesiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.