GGZ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Oxyhemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7500
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Stat Profile Prime Plus Analyzer System (K200204) | Nova Biomedical Corporation | 2020-04-06 |
| Stat Profile Prime Plus Analyzer System (K180186) | Nova Biomedical Corporation | 2018-08-23 |
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