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

    EXTRACORPOREAL BLOOD GAS SYSTEM

    K Number: K822000 · Decision Dec 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    8
    Review Days
    168

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    Basic Information

    Device Name
    EXTRACORPOREAL BLOOD GAS SYSTEM
    K Number
    K822000
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4410
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardiovascular Devices, Inc.
    Date Received
    July 7, 1982
    Decision Date
    December 22, 1982
    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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    K864703 MODIFIED GAS-STAT(TM) MONITORING SYSTEM
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