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510(k) K830629

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

K830629 is an FDA 510(k) premarket notification submitted by Cobe Laboratories, Inc. for the device "COBE RX METER". The FDA issued a decision of Substantially Equivalent on April 6, 1983. The device falls under product code FLB (Meter, Conductivity, Induction, Remote Type), a Class II device regulated under 21 CFR 876.5820. Cobe Laboratories, Inc. has at least 10 other 510(k) clearances on record.

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

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)
  • K905793 — COBE CENTRY 2 BICART OPTION KIT (February 12, 1991)
  • K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT (February 11, 1991)
  • 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)

Other clearances for product code FLB

  • K100237 — DIALYSATE METER, MODEL D-6 (April 23, 2010)
  • K925210 — 90DX MULTITEST METER, MODIFICATION (January 25, 1994)
  • 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)

FDA data resources