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