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510(k) K940188

PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM by Biomedical Sensors, Ltd. — Product Code CCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1995
Date Received
January 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Device Class
Class II
Regulation Number
868.1150
Review Panel
AN
Submission Type

Other clearances by Biomedical Sensors, Ltd.

  • K953893 — PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (November 4, 1997)
  • K862069 — CARDIOMET 4000 GAS MONITORING SYSTEMS (July 18, 1986)

Other clearances for product code CCC

  • K071165 — ISCALERT SENSOR SYSTEM (November 7, 2007)
  • K983198 — TRENDCARE CALIBRATOR MODEL SCU 7007 (November 23, 1999)
  • K972314 — PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIO (December 19, 1997)
  • K953893 — PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (November 4, 1997)
  • K961790 — POINT-OF-CARE BLOOD GAS MONITOR SYSTEM (April 9, 1997)
  • K963935 — OLYMPUS CRITICAL CARE MONITORING SYSTEM (January 23, 1997)
  • K951094 — POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM (January 16, 1996)
  • K931185 — SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE (October 21, 1993)
  • K901548 — BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS (January 14, 1991)
  • K891013 — MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING (August 2, 1989)