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510(k) K830629

COBE RX METER by Cobe Laboratories, Inc. — Product Code FLB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1983
Date Received
March 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Conductivity, Induction, Remote Type
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR (December 27, 1990)
  • K902631 — COBE ICU CONVERSION KIT (December 17, 1990)
  • K902437 — COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER (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)

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  • K882032 — MODEL 90DX MULTITEST METER (August 11, 1988)
  • K821415 — MODEL 90 BC (May 27, 1982)
  • K770263 — DIALYSATE METER RS-2100A, CIRCUIT CHANGE (February 18, 1977)