FJFClass II
Detector, Air Bubble
21 CFR 876.5820 / Gastroenterology, Urology
FJF is the FDA product code for Detector, Air Bubble, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- FJF
- Device name
- Detector, Air Bubble
- Regulation
- 21 CFR 876.5820
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code FJF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 2 |
| 1989 | 1 |
| 1991 | 1 |
Applicants with the most clearances
Product code FJF| Applicant | Clearances |
|---|---|
| American Orthodontics | 1 |
| BD Becton Dickinson Vacutainer Systems Preanalytic | 1 |
| Cobe Laboratories, Inc. | 1 |
| Hospal Medical Corp. | 1 |
| Medivators Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code FJF.
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.