FJB — Detector, Dialysate Level Class II
FDA product code FJB covers "Detector, Dialysate Level", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FJB
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K883490 | national medical care, medical products div | ACCUFLO UF CONTROL MODULE NO. 74-0100-3 | September 29, 1988 |
| K881062 | cobe laboratories | CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 | April 21, 1988 |
| K875312 | yankee intl. medical research and mfg | UFR DIGITAL RETROFIT | February 19, 1988 |