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510(k) K961790

POINT-OF-CARE BLOOD GAS MONITOR SYSTEM by Optical Sensors, Inc. — Product Code CCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1997
Date Received
May 9, 1996
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

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  • 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)

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  • K953893 — PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (November 4, 1997)
  • K963935 — OLYMPUS CRITICAL CARE MONITORING SYSTEM (January 23, 1997)
  • K951094 — POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM (January 16, 1996)
  • K940188 — PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (November 13, 1995)
  • 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)