CBZClass II
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
21 CFR 868.1170 / Anesthesiology
CBZ is the FDA product code for Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling, a class II device type, regulated under 21 CFR 868.1170. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- CBZ
- Device name
- Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
- Regulation
- 21 CFR 868.1170
- 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
- 10
- Ingested recalls
- 1
Clearances, product code CBZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1981 | 1 |
| 1986 | 1 |
| 1989 | 1 |
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 1 |
| 1997 | 1 |
| 2002 | 1 |
Applicants with the most clearances
Product code CBZ| Applicant | Clearances |
|---|---|
| Biochem International, Inc. | 2 |
| Medtronic, Inc. | 2 |
| 3M Company | 1 |
| Abbott Medical | 1 |
| Cardiovascular Devices, Inc. | 1 |
| Diametrics Medical, Inc. | 1 |
| Terumo Cardiovascular Systems Corporation | 1 |
| Vascular Technology Incorporated | 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.
