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510(k) K790546

FLOWMETER, OPTIFLO GAS by Cobe Laboratories, Inc. — Product Code DTX

K790546 is an FDA 510(k) premarket notification submitted by Cobe Laboratories, Inc. for the device "FLOWMETER, OPTIFLO GAS". The FDA issued a decision of Substantially Equivalent on May 11, 1979. The device falls under product code DTX (Gas Control Unit, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4300. Cobe Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1979
Date Received
March 20, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Control Unit, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4300
Review Panel
CV
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 DTX

  • K210669 — Quantum Mini Ventilation Module (May 4, 2021)
  • K202733 — Quantum Ventilation Module (October 16, 2020)
  • K181942 — Quantum Ventilation Module (October 18, 2018)
  • K101046 — STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM (December 9, 2010)
  • K023745 — SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G (January 17, 2003)
  • K965214 — COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) (March 28, 1997)
  • K863902 — MODIFIED SARNS MEMBRANE OXYGENATOR (December 11, 1986)
  • K822820 — GAS-FLOW METER GFL 10 (October 18, 1982)
  • K792348 — STANICOR, OMNI-STAN,MOD 333B,334A GAMMA (December 5, 1979)

FDA data resources