QEM
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cerebral Oximeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Medical specialty
- Cardiovascular
- FDA definition
- Oximeter to measure cerebral tissue saturation
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VO200 – NeurOs Cerebral Oximetry System (K182242) | Mespere Lifesciences, Inc. | 2018-12-26 |
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