FIL — System, Dialysate Delivery, Single Pass Class II
FDA product code FIL covers "System, Dialysate Delivery, Single Pass", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- FIL
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- 510(k)
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K011741 | Hemametrics | CRIT-LINE MONITOR III TQA (CLM TQA) | Jul 23, 2002 |
| K901038 | Baxter Healthcare | SPS 550-IPS (INTEGRATED PATIENT STATION) | Apr 19, 1990 |
| K890329 | Fresenius Usa | FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM | May 11, 1989 |
| K790824 | Cyberex | REPGREEN ULTRAFILTRATION MONITOR | Jun 27, 1979 |
| K781633 | Extracorporeal Medical Specialities | ULTRAFILTRATION SCALE | Dec 7, 1978 |
| K771875 | Travenol Laboratories | ULTRAFILTRATION MONITOR 5M9034 | Nov 30, 1977 |
| K771227 | Gambro | AK-10 | Aug 2, 1977 |
| K770137 | Travenol Laboratories | NEGATIVE PRESSURE ADAPTER 5M1350 | Feb 1, 1977 |