FDA product code QWE: Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
QWE is the FDA product code for hyperoxia monitoring device adjunct to pulse oximetry. It is a Class II device, regulated under 21 CFR 870.2720 and reviewed by the Anesthesiology panel. Devices under QWE 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 hyperoxia monitoring device adjunct to pulse oximetry is a device that monitors elevated hemoglobin oxygen saturation levels as an adjunct to arterial oxygen saturation monitoring.
Classification
| Field | Value |
|---|---|
| Device name | Hyperoxia Monitoring Device Adjunct To Pulse Oximetry |
| Device class | Class II |
| Regulation | 21 CFR 870.2720 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
Recalls for QWE devices
openFDA lists no recalls for product code QWE.
Frequently asked questions
What is FDA product code QWE?
QWE is the FDA product code for hyperoxia monitoring device adjunct to pulse oximetry. It is a Class II device, regulated under 21 CFR 870.2720 and reviewed by the Anesthesiology panel.
What device class is QWE?
Class II, regulation 21 CFR 870.2720. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QWE
- Run a recall and safety report across every QWE manufacturer
- Watch product code QWE 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.