CCI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Analyzer, Gas, Nitrogen, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1690
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1997: 1 · 2000: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CO2/02 MONITOR MULTINEX (K872024) | Datascope Corp. | 1988-03-31 |
| CAPILLARY SAMPLE LINE (K771516) | Mcgaw Respiratory Therapy | 1977-08-16 |
Track CCI automatically
Every clearance here is in the API, with alerts when new ones post.