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510(k) K955423

PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM by Fresenius USA, Inc. — Product Code FKP

K955423 is an FDA 510(k) premarket notification submitted by Fresenius USA, Inc. for the device "PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM". The FDA issued a decision of Substantially Equivalent on June 13, 1996. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), 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
June 13, 1996
Date Received
November 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Patient
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)
  • K955762 — PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (July 31, 1996)
  • K961706 — P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL (July 31, 1996)
  • K941460 — FRESENIUS BLOOD TEMPERATURE MONITOR (July 3, 1996)
  • K930181 — BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (November 29, 1995)
  • K944767 — DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER (November 29, 1995)

Other clearances for product code FKP

  • K181991 — NxStage Connected Health System (September 26, 2018)
  • K131739 — NXSTAGE CONNECTED HEALTH SYSTEM (October 10, 2013)
  • K130460 — NXSTAGE DOSING CALCULATOR (July 11, 2013)
  • K040074 — ONEVIEW INTERFACE (April 8, 2004)
  • K021060 — FRESENIUS ICARE MONITORING SYSTEM (November 13, 2002)
  • K003615 — STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS (February 1, 2001)
  • K992255 — CKHEMO, MODEL CKHEMO VERSION 1.0 (November 30, 1999)
  • K964264 — HIGH RANGE PEROXIDE TEST STRIP (June 16, 1997)
  • K953854 — WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE (March 11, 1996)
  • K930181 — BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (November 29, 1995)

FDA data resources