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

    EMS SWISS LITHOCLAST LITHOTRIPTER

    K Number: K963285 · Decision Feb 13, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    60
    Applicant Total
    9
    Review Days
    176

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    Basic Information

    Device Name
    EMS SWISS LITHOCLAST LITHOTRIPTER
    K Number
    K963285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4480
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Electro Medical Systems SA
    Date Received
    August 21, 1996
    Decision Date
    February 13, 1997
    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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    Other Clearances by Electro Medical Systems SA

    K Number Device Name
    K022328 EMS PIEZON MASTER 600
    K022119 EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE
    K012445 EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
    K002484 EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
    K992251 SWISS LITHOCLAST MULTIPURPOSE PROBE
    K964111 LITHOVAC SUCTION/ASPIRATION PROBE
    K953026 MINIPIEZON
    K951531 SWISS LITHOCLAST LITHOTRIPTER