510(k) K874020
- Device
- Ultracare(tm) Automated Patient Assist Device
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K874020
- Product code
- KPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-01-29
- Date received
- 1987-10-02
- Regulation
- 876.5630
- Classification name
- System, Dialysate Delivery, Semi-Automatic, Peritoneal
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- FREDERICK GUSTAFSON
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 1225714
- 1649518
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KPF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061515 | RENALSOFT | Baxter Healthcare Corp | 2006-09-11 |
| K990953 | RENAL LINK | Baxter Healthcare Corp | 1999-06-18 |
| K970989 | CYBERREN | Cybernius Medical , Ltd. | 1997-07-24 |
| K955762 | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | Fresenius USA, Inc. | 1996-07-31 |
| K913515 | TOTAL CONTAINMENT DEVICE | Denco | 1994-05-26 |
| K875121 | AMICON EQUALINE FLUID BALANCE SYSTEM | Amicon, Inc. | 1988-02-19 |
| K821328 | C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP | Medionics International , Ltd. | 1982-07-28 |
| K802831 | GAMBRO PERITONEAL DIALYSIS MONITOR | Gambro, Inc. | 1980-12-18 |
| K800496 | CYCLER W/5 OR 10 HR. FILL/DWELL TIMER | American Medical Products, Inc. | 1980-07-21 |
| K791676 | PERITONEAL DIALYSIS CYCLER MODEL PDC1000 | J.M. Sounds Electronics Co. | 1979-12-06 |
| K791584 | CYLER/HEATER FOR PERITONEAL DIALYSIS | American Medical Products, Inc. | 1979-11-16 |
| K790091 | AMP AUTOMATIC CYCLER STAND | American Medical Products, Inc. | 1979-02-16 |