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

    DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM

    K Number: K052934 · Decision Jun 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    88
    Applicant Total
    1
    Review Days
    236

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    Basic Information

    Device Name
    DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
    K Number
    K052934
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5300
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    S.O.R. Internacional, S.A.
    Date Received
    October 19, 2005
    Decision Date
    June 12, 2006
    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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