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

    MAST FOR BASIC HEATER-COOLER UNIT 16-09-00

    K Number: K883332 · Decision Sep 26, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    89
    Applicant Total
    174
    Review Days
    49

    Basic Information

    Device Name
    MAST FOR BASIC HEATER-COOLER UNIT 16-09-00
    K Number
    K883332
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    SHILEY, INC.
    Date Received
    August 8, 1988
    Decision Date
    September 26, 1988
    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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