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

    ULTRATHERM (908)

    K Number: K964083 · Decision Apr 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    44
    Applicant Total
    2
    Review Days
    174

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    Basic Information

    Device Name
    ULTRATHERM (908)
    K Number
    K964083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5290
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sie-Med, Inc.
    Date Received
    October 11, 1996
    Decision Date
    April 3, 1997
    Product Code
    IMJ
    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
    IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

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    Other Clearances by Sie-Med, Inc.

    K Number Device Name
    K003130 REGUTHERM 952 THERMOGRAPHIC SYSTEM