QVT

Monitor For Opioid Induced Impairment Of Oxygenation

Product code
QVT
Device name
Monitor For Opioid Induced Impairment Of Oxygenation
Device class
Class 2
21 CFR
21 CFR 868.2250
Medical specialty
Anesthesiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QVT
Classification and pathway per current FDA publications. Data from openFDA (CC0).