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

    SWISS LITHOBREAKER

    K Number: K123038 · Decision Jan 16, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    60
    Applicant Total
    28
    Review Days
    110

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    Basic Information

    Device Name
    SWISS LITHOBREAKER
    K Number
    K123038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4480
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E.M.S Electro Medical Systems S.A
    Date Received
    September 28, 2012
    Decision Date
    January 16, 2013
    Product Code
    FFK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FFK Lithotriptor, Electro-Hydraulic

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