BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    CARDIOMET 4000 GAS MONITORING SYSTEMS

    K Number: K862069 · Decision Jul 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    49

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    Basic Information

    Device Name
    CARDIOMET 4000 GAS MONITORING SYSTEMS
    K Number
    K862069
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Biomedical Sensors, Inc.
    Date Received
    May 30, 1986
    Decision Date
    July 18, 1986
    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 Biomedical Sensors, Inc.

    K Number Device Name
    K953893 PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM