QWE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2720
- Medical specialty
- Anesthesiology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| ORi (DEN200076) | Masimo Corporation | 2023-10-12 |
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