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

    FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917

    K Number: K924023 · Decision Apr 14, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    6
    Applicant Total
    5
    Review Days
    246

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    Basic Information

    Device Name
    FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917
    K Number
    K924023
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5950
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ferno
    Date Received
    August 11, 1992
    Decision Date
    April 14, 1993
    Product Code
    IRQ
    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
    IRQ Unit, Heating, Powered

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