CBR
5 FDA 510(k) clearances · Product code
117 daysmedian time to decision
214 days90th percentile
5clearances measured
FDA profile
- Official device name
- Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1700
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 1 · 1996: 1 · 2004: 1 · 2006: 2 · 2012: 8
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 |
|---|---|---|
| SPEACELABS MULTIGAS MODULE (K112173) | Spacelabs Healthcare | 2011-10-05 |
| SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES (K053599) | Spacelabs Medical, Inc. | 2006-04-19 |
| SPACELABS MEDICAL MULTIGAS ANALYZER (K954962) | Spacelabs, Inc. | 1996-05-31 |
| OSCAR(TM) II CAPNOMETER & PULSE OXIMETER (K904843) | Dalton Instrument Corp. | 1991-04-09 |
| N20 TEST (K853360) | Erich Jaeger, Inc. | 1985-09-03 |
Track CBR automatically
Every clearance here is in the API, with alerts when new ones post.