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

    SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM

    K Number: K070779 · Decision Jul 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    17
    Review Days
    476

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    Basic Information

    Device Name
    SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM
    K Number
    K070779
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Misonix, Inc.
    Date Received
    March 21, 2007
    Decision Date
    July 9, 2008
    Product Code
    NTB
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NTB System, Ablation, Ultrasound And Accessories

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