FDA 510(k) Applications Submitted by GAMBRO HEALTHCARE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K970253 |
01/22/1997 |
COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET |
GAMBRO HEALTHCARE |
| K990039 |
01/06/1999 |
GAMBRO DQM 200 |
GAMBRO HEALTHCARE |
| K980386 |
02/02/1998 |
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) |
GAMBRO HEALTHCARE |
| K982413 |
07/13/1998 |
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS |
GAMBRO HEALTHCARE |
| K982414 |
07/13/1998 |
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS |
GAMBRO HEALTHCARE |
| K982818 |
08/11/1998 |
HOSPAL TIPSTOP |
GAMBRO HEALTHCARE |
| K994390 |
12/28/1999 |
GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER |
GAMBRO HEALTHCARE |
| K974899 |
12/30/1997 |
GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H |
GAMBRO HEALTHCARE |
| K962427 |
06/24/1996 |
COBE CENTRYSYSTEM 700 HG HEMODIALYZER |
GAMBRO HEALTHCARE |
| K954623 |
10/05/1995 |
REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) |
GAMBRO HEALTHCARE |
| K981085 |
03/25/1998 |
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM |
GAMBRO HEALTHCARE |
| K981681 |
05/13/1998 |
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) |
GAMBRO HEALTHCARE |
| K982760 |
08/06/1998 |
COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET |
GAMBRO HEALTHCARE |
|
|
