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510(k) K890329

FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM by Fresenius USA, Inc. — Product Code FIL

K890329 is an FDA 510(k) premarket notification submitted by Fresenius USA, Inc. for the device "FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on May 11, 1989. The device falls under product code FIL (System, Dialysate Delivery, Single Pass), a Class II device regulated under 21 CFR 876.5820. Fresenius USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1989
Date Received
January 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Pass
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Fresenius USA, Inc.

  • K992275 — FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VO (August 4, 1999)
  • K970700 — FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX (September 15, 1998)
  • K974584 — FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F80 (May 14, 1998)
  • K973378 — C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SE (November 3, 1997)
  • K961465 — 2008H ON LINE CLEARANCE MONITOR (July 3, 1997)
  • K961706 — P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL (July 31, 1996)
  • K955762 — PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (July 31, 1996)
  • K941460 — FRESENIUS BLOOD TEMPERATURE MONITOR (July 3, 1996)
  • K955423 — PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (June 13, 1996)
  • K930181 — BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (November 29, 1995)

Other clearances for product code FIL

  • K011741 — CRIT-LINE MONITOR III TQA (CLM TQA) (July 23, 2002)
  • K901038 — SPS 550-IPS (INTEGRATED PATIENT STATION) (April 19, 1990)
  • K790824 — REPGREEN ULTRAFILTRATION MONITOR (June 27, 1979)
  • K781633 — ULTRAFILTRATION SCALE (December 7, 1978)
  • K771875 — ULTRAFILTRATION MONITOR 5M9034 (November 30, 1977)
  • K771227 — AK-10 (August 2, 1977)
  • K770137 — NEGATIVE PRESSURE ADAPTER 5M1350 (February 1, 1977)

FDA data resources