BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STEAM PAK MOIST HEAT

    K Number: K832803 · Decision Sep 20, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    7
    Applicant Total
    6
    Review Days
    33

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    Basic Information

    Device Name
    STEAM PAK MOIST HEAT
    K Number
    K832803
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5730
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Electro-Med Health Industries, Inc.
    Date Received
    August 18, 1983
    Decision Date
    September 20, 1983
    Product Code
    IMA
    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
    IMA Pack, Heat, Moist

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