BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    Swiss LithoClast Trilogy

    K Number: K181997 · Decision Aug 30, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    13
    Applicant Total
    28
    Review Days
    35

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    Basic Information

    Device Name
    Swiss LithoClast Trilogy
    K Number
    K181997
    Device Class
    FDA class 2
    Clearance Type
    Special
    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
    July 26, 2018
    Decision Date
    August 30, 2018
    Product Code
    FEO
    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
    FEO Lithotriptor, Ultrasonic

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