QVT

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Monitor For Opioid Induced Impairment Of Oxygenation

Device class

Class II (moderate risk)

Regulation

21 CFR 868.2250

Medical specialty

Anesthesiology

FDA 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

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