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

    RAPID PROGRAMMER, VERSION 3.3.0

    K Number: K091993 · Decision Jul 31, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    138
    Applicant Total
    1
    Review Days
    29

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    Basic Information

    Device Name
    RAPID PROGRAMMER, VERSION 3.3.0
    K Number
    K091993
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5880
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Advanced Neuromodulation Systems, Inc. (Ans Inc.)
    Date Received
    July 2, 2009
    Decision Date
    July 31, 2009
    Product Code
    GZB
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)

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