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

    THERMAL CONDITIONING SYSTEM

    K Number: K791154 · Decision Oct 9, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    259
    Registration Numbers
    259
    Same Product Code
    41
    Applicant Total
    1
    Review Days
    111

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    Basic Information

    Device Name
    THERMAL CONDITIONING SYSTEM
    K Number
    K791154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5740
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Acurex Aerotherm
    Date Received
    June 20, 1979
    Decision Date
    October 9, 1979
    Product Code
    IRT
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IRT Pad, Heating, Powered

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