QWE — Hyperoxia Monitoring Device Adjunct To Pulse Oximetry Class II
FDA product code QWE covers "Hyperoxia Monitoring Device Adjunct To Pulse Oximetry", a Class II medical device regulated under 21 CFR 870.2720. Submissions are reviewed by the Anesthesiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QWE
- Device Class
- Class II
- Regulation Number
- 870.2720
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200076 | Masimo Corporation | ORi | Oct 12, 2023 |