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510(k) K884228

CDI(R) 2000 BLOOD GAS MONITOR by Cardiovascular Devices, Inc. — Product Code CBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1989
Date Received
October 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Device Class
Class II
Regulation Number
868.1170
Review Panel
AN
Submission Type

Other clearances by Cardiovascular Devices, Inc.

  • K890113 — THE CDI(R) SYSTEM 400 (May 23, 1989)
  • K871221 — CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300 (June 5, 1987)
  • K864703 — MODIFIED GAS-STAT(TM) MONITORING SYSTEM (February 19, 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 CBZ

  • K020967 — TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM (June 20, 2002)
  • K970906 — PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 (September 23, 1997)
  • K931112 — MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI (June 1, 1993)
  • K920061 — HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM (March 30, 1992)
  • K912030 — CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED (October 30, 1991)
  • K912428 — PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT (August 9, 1991)
  • K862114 — KHURI REGIONAL TISSUE PH MONITOR (June 25, 1986)
  • K803260 — SENSOMAT MUSCLE/TISSUE PH (February 2, 1981)
  • K803014 — SENSOMAT (December 22, 1980)