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

    ADVANTAGE PADDLE

    K Number: K033202 · Decision Dec 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    175
    Applicant Total
    1
    Review Days
    62

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    Basic Information

    Device Name
    ADVANTAGE PADDLE
    K Number
    K033202
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Livingston Products, Inc.
    Date Received
    October 2, 2003
    Decision Date
    December 3, 2003
    Product Code
    IZH
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IZH System, X-Ray, Mammographic

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