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

    LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS

    K Number: K033335 · Decision Nov 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    3
    Applicant Total
    781
    Review Days
    40

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    Basic Information

    Device Name
    LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
    K Number
    K033335
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4890
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Solutions USA, Inc.
    Date Received
    October 16, 2003
    Decision Date
    November 25, 2003
    Product Code
    MMZ
    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
    MMZ Table, Cystometric, Electric

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