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510(k) K864703

MODIFIED GAS-STAT(TM) MONITORING SYSTEM by Cardiovascular Devices, Inc. — Product Code DTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1987
Date Received
December 2, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4410
Review Panel
CV
Submission Type

Other clearances by Cardiovascular Devices, Inc.

  • K890113 — THE CDI(R) SYSTEM 400 (May 23, 1989)
  • K884228 — CDI(R) 2000 BLOOD GAS MONITOR (January 30, 1989)
  • K871221 — CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300 (June 5, 1987)
  • K843912 — INTRAVASCULAR BLOOD GAS SYSTEM (January 10, 1985)
  • K840749 — GAST STAT MONITORING SYSTEM (April 17, 1984)
  • K831225 — GAS-STAT MONITORING SYSTEM (May 27, 1983)
  • K822000 — EXTRACORPOREAL BLOOD GAS SYSTEM (December 22, 1982)

Other clearances for product code DTY

  • K093650 — BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM (February 17, 2010)
  • K963698 — CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 (March 20, 1997)
  • K954501 — BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM (January 16, 1996)
  • K902654 — CDI (TM) SYSTEM 100 MONITORING SYSTEM (November 5, 1990)
  • K900860 — PERFUSION MONITOR (August 14, 1990)
  • K840749 — GAST STAT MONITORING SYSTEM (April 17, 1984)
  • K822000 — EXTRACORPOREAL BLOOD GAS SYSTEM (December 22, 1982)