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510(k) K970906

PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR by Diametrics Medical, Ltd. — Product Code CBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1997
Date Received
March 12, 1997
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

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Other clearances for product code CBZ

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  • 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)
  • K884228 — CDI(R) 2000 BLOOD GAS MONITOR (January 30, 1989)
  • K862114 — KHURI REGIONAL TISSUE PH MONITOR (June 25, 1986)
  • K803260 — SENSOMAT MUSCLE/TISSUE PH (February 2, 1981)
  • K803014 — SENSOMAT (December 22, 1980)