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510(k) K904336

NEW COBE SATURATION/HEMATOCRIT MONITOR by Cobe Laboratories, Inc. — Product Code GKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1990
Date Received
September 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Hematocrit, Automated
Device Class
Class II
Regulation Number
864.5600
Review Panel
HE
Submission Type

Other clearances by Cobe Laboratories, Inc.

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  • K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC (March 22, 1991)
  • K905793 — COBE CENTRY 2 BICART OPTION KIT (February 12, 1991)
  • K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT (February 11, 1991)
  • 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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