FDA Product Code
FDA Product Code KPF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5630
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K061515 | RENALSOFT | Baxter Healthcare Corp | 2006-09-11 | Traditional | PDF ↗ |
| K990953 | RENAL LINK | Baxter Healthcare Corp | 1999-06-18 | Traditional | PDF ↗ |
| K970989 | CYBERREN | Cybernius Medical , Ltd. | 1997-07-24 | Traditional | PDF ↗ |
| K955762 | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | Fresenius USA, Inc. | 1996-07-31 | Traditional | PDF ↗ |
| K913515 | TOTAL CONTAINMENT DEVICE | Denco | 1994-05-26 | Traditional | PDF ↗ |
| K875121 | AMICON EQUALINE FLUID BALANCE SYSTEM | Amicon, Inc. | 1988-02-19 | Traditional | PDF ↗ |
| K874020 | ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE | Abbott Laboratories | 1988-01-29 | Traditional | PDF ↗ |
| K821328 | C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP | Medionics International , Ltd. | 1982-07-28 | Traditional | PDF ↗ |
| K802831 | GAMBRO PERITONEAL DIALYSIS MONITOR | Gambro, Inc. | 1980-12-18 | Traditional | PDF ↗ |
| K800496 | CYCLER W/5 OR 10 HR. FILL/DWELL TIMER | American Medical Products, Inc. | 1980-07-21 | Traditional | PDF ↗ |
| K791676 | PERITONEAL DIALYSIS CYCLER MODEL PDC1000 | J.M. Sounds Electronics Co. | 1979-12-06 | Traditional | PDF ↗ |
| K791584 | CYLER/HEATER FOR PERITONEAL DIALYSIS | American Medical Products, Inc. | 1979-11-16 | Traditional | PDF ↗ |
| K790091 | AMP AUTOMATIC CYCLER STAND | American Medical Products, Inc. | 1979-02-16 | Traditional | PDF ↗ |
Product code KPF · Class II · Gastroenterology, Urology. Data: openFDA.