CBRClass II
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
21 CFR 868.1700 / Anesthesiology
CBR is the FDA product code for Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.), a class II device type, regulated under 21 CFR 868.1700. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 3 recalls.
Classification record
- Product code
- CBR
- Device name
- Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- Regulation
- 21 CFR 868.1700
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 5
- Ingested recalls
- 3
Clearances, product code CBR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1991 | 1 |
| 1996 | 1 |
| 2006 | 1 |
| 2011 | 1 |
Applicants with the most clearances
Product code CBR| Applicant | Clearances |
|---|---|
| GE Healthcare | 2 |
| Dalton Instrument Corp. | 1 |
| Erich Jaeger, Inc. | 1 |
| Spacelabs, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- AD Supply Group Limited
- Advanced Instrumentations, Inc.
- AirLife Finland Oy
- Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- Caf Medical Solutions Inc
- CBR Enterprise Limited
- Change Healthcare Canada Company
- Datascope Corp.
- DHL Supply Chain (Netherlands) B.V.
- Draeger Medical Systems, Inc.
- Draegerwerk AG & Co. KGaA
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
