FDA 510(k) Applications Submitted by FRESENIUS USA, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K970700 |
02/25/1997 |
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX |
FRESENIUS USA, INC. |
| K941460 |
03/25/1994 |
FRESENIUS BLOOD TEMPERATURE MONITOR |
FRESENIUS USA, INC. |
| K961465 |
04/17/1996 |
2008H ON LINE CLEARANCE MONITOR |
FRESENIUS USA, INC. |
| K961706 |
05/02/1996 |
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR |
FRESENIUS USA, INC. |
| K955423 |
11/28/1995 |
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM |
FRESENIUS USA, INC. |
| K955762 |
12/18/1995 |
PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM |
FRESENIUS USA, INC. |
| K992275 |
07/07/1999 |
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS |
FRESENIUS USA, INC. |
| K973378 |
09/08/1997 |
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 |
FRESENIUS USA, INC. |
| K974584 |
12/08/1997 |
FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS |
FRESENIUS USA, INC. |
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