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

    MPS M ELECTRODE

    K Number: K002801 · Decision May 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    55
    Applicant Total
    1
    Review Days
    238

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    Basic Information

    Device Name
    MPS M ELECTRODE
    K Number
    K002801
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5990
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Medical Physics and Services, Inc.
    Date Received
    September 8, 2000
    Decision Date
    May 4, 2001
    Product Code
    LNS
    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
    LNS Lithotriptor, Extracorporeal Shock-Wave, Urological

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