CCJClass II
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
21 CFR 868.1430 / Anesthesiology
CCJ is the FDA product code for Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase, a class II device type, regulated under 21 CFR 868.1430. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- CCJ
- Device name
- Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- Regulation
- 21 CFR 868.1430
- 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
- 28
- Ingested recalls
- 1
Clearances, product code CCJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1987 | 1 |
| 1989 | 2 |
| 1990 | 2 |
| 1991 | 1 |
| 1996 | 2 |
| 2000 | 1 |
| 2008 | 2 |
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code CCJ| Applicant | Clearances |
|---|---|
| Bedfont Scientific Ltd. | 5 |
| Capnia Inc | 4 |
| Vitalograph, Inc. | 2 |
| Bacharach, Inc. | 1 |
| BD Becton Dickinson Vacutainer Systems Preanalytic | 1 |
| Bedfont Technical Instruments, Ltd. | 1 |
| Carrot Sense, Inc. | 1 |
| Carrot, Inc. | 1 |
| Catalyst Research Corp. | 1 |
| Erich Jaeger, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
