BSE
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Analyzer, Gas, Helium, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1640
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PANDA HELIUM GAS ANALYZER (K903939) | Medical Associated Services, Inc. | 1991-01-03 |
| HE TEST (K843843) | Erich Jaeger, Inc. | 1984-12-04 |
| SPIROLOOP (K841858) | Datamed, Inc. | 1984-07-11 |
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Every clearance here is in the API, with alerts when new ones post.