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510(k) K953893

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

K953893 is an FDA 510(k) premarket notification submitted by Biomedical Sensors, Inc. for the device "PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 4, 1997. The device falls under product code CCC (Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1150. Biomedical Sensors, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1997
Date Received
August 17, 1995
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, Inc.

  • K940188 — PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (November 13, 1995)
  • 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)
  • 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)
  • 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)

FDA data resources