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

    HEATER-COOLER UNIT HCU 40

    K Number: K130300 · Decision Jul 1, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    29
    Applicant Total
    44
    Review Days
    144

    Basic Information

    Device Name
    HEATER-COOLER UNIT HCU 40
    K Number
    K130300
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MAQUET CARDIOPULMONARY AG
    Date Received
    February 7, 2013
    Decision Date
    July 1, 2013
    Product Code
    DWC
    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
    DWC Controller, Temperature, Cardiopulmonary Bypass

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