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

    GAST STAT MONITORING SYSTEM

    K Number: K840749 · Decision Apr 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    8
    Review Days
    54

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    Basic Information

    Device Name
    GAST STAT MONITORING SYSTEM
    K Number
    K840749
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4410
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardiovascular Devices, Inc.
    Date Received
    February 23, 1984
    Decision Date
    April 17, 1984
    Product Code
    DTY
    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
    DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

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