Monitor For Opioid Induced Impairment Of Oxygenation
QVT · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.2250
Classification
FDA Product Code
QVT
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.2250
Review panel
AN
Medical specialty
Anesthesiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose