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

    MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS

    K Number: K051773 · Decision Jul 28, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    138
    Applicant Total
    1
    Review Days
    27

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    Basic Information

    Device Name
    MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS
    K Number
    K051773
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5880
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Inc.,Neurological Division.
    Date Received
    July 1, 2005
    Decision Date
    July 28, 2005
    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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