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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    SD-956 ULTRASOUND THERAPY

    K Number: K981449 · Decision Dec 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    88
    Applicant Total
    20
    Review Days
    233

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    Basic Information

    Device Name
    SD-956 ULTRASOUND THERAPY
    K Number
    K981449
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5300
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Skylark Device Co., Ltd.
    Date Received
    April 22, 1998
    Decision Date
    December 11, 1998
    Product Code
    IMI
    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
    IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

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