FDA product code QVT: Monitor For Opioid Induced Impairment Of Oxygenation
QVT is the FDA product code for monitor for opioid induced impairment of oxygenation. It is a Class II device, regulated under 21 CFR 868.2250 and reviewed by the Anesthesiology panel. Devices under QVT reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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
Classification
| Field | Value |
|---|---|
| Device name | Monitor For Opioid Induced Impairment Of Oxygenation |
| Device class | Class II |
| Regulation | 21 CFR 868.2250 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
Recalls for QVT devices
openFDA lists no recalls for product code QVT.
Frequently asked questions
What is FDA product code QVT?
QVT is the FDA product code for monitor for opioid induced impairment of oxygenation. It is a Class II device, regulated under 21 CFR 868.2250 and reviewed by the Anesthesiology panel.
What device class is QVT?
Class II, regulation 21 CFR 868.2250. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QVT
- Run a recall and safety report across every QVT manufacturer
- Watch product code QVT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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