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

    MODIFIED GAS-STAT(TM) MONITORING SYSTEM

    K Number: K864703 · Decision Feb 19, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    8
    Review Days
    79

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    Basic Information

    Device Name
    MODIFIED GAS-STAT(TM) MONITORING SYSTEM
    K Number
    K864703
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4410
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardiovascular Devices, Inc.
    Date Received
    December 2, 1986
    Decision Date
    February 19, 1987
    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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    Other Clearances by Cardiovascular Devices, Inc.

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    K890113 THE CDI(R) SYSTEM 400
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