BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GAS-STAT MONITORING SYSTEM

    K Number: K831225 · Decision May 27, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    46
    Applicant Total
    8
    Review Days
    42

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    Basic Information

    Device Name
    GAS-STAT MONITORING SYSTEM
    K Number
    K831225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardiovascular Devices, Inc.
    Date Received
    April 15, 1983
    Decision Date
    May 27, 1983
    Product Code
    DRY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

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    Other Clearances by Cardiovascular Devices, Inc.

    K Number Device Name
    K890113 THE CDI(R) SYSTEM 400
    K884228 CDI(R) 2000 BLOOD GAS MONITOR
    K871221 CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300
    K864703 MODIFIED GAS-STAT(TM) MONITORING SYSTEM
    K843912 INTRAVASCULAR BLOOD GAS SYSTEM
    K840749 GAST STAT MONITORING SYSTEM
    K822000 EXTRACORPOREAL BLOOD GAS SYSTEM