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510(k) K905793

COBE CENTRY 2 BICART OPTION KIT by Cobe Laboratories, Inc. — Product Code FKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1991
Date Received
December 27, 1990
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 Cobe Laboratories, Inc.

  • K923272 — COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR (May 11, 1993)
  • K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC (March 22, 1991)
  • K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT (February 11, 1991)
  • K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR (December 27, 1990)
  • K902437 — COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER (December 17, 1990)
  • K902631 — COBE ICU CONVERSION KIT (December 17, 1990)
  • K904566 — NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER (December 12, 1990)
  • K902758 — COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC (August 23, 1990)
  • K902759 — COBE CLOSED WOUND DRAINAGE KIT (July 18, 1990)
  • K902671 — COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER (July 17, 1990)

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  • 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)
  • K955423 — PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (June 13, 1996)
  • K953854 — WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE (March 11, 1996)