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

    COBE HEAT EXCHANGER RESERVOIR MODULE

    K Number: K812093 · Decision Aug 13, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    90
    Applicant Total
    77
    Review Days
    20

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    Basic Information

    Device Name
    COBE HEAT EXCHANGER RESERVOIR MODULE
    K Number
    K812093
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cobe Laboratories, Inc.
    Date Received
    July 24, 1981
    Decision Date
    August 13, 1981
    Product Code
    DTR
    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
    DTR Heat-Exchanger, Cardiopulmonary Bypass

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