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

    THERMOFONTE AIR MESSAGE BATH

    K Number: K821809 · Decision Jul 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    35

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    Basic Information

    Device Name
    THERMOFONTE AIR MESSAGE BATH
    K Number
    K821809
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5100
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Greenfields
    Date Received
    June 18, 1982
    Decision Date
    July 23, 1982
    Product Code
    ILJ
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ILJ Bath, Hydro-Massage

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