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

    NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES

    K Number: K010969 · Decision Apr 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    74
    Review Days
    18

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    Basic Information

    Device Name
    NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
    K Number
    K010969
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Instruments
    Date Received
    April 2, 2001
    Decision Date
    April 20, 2001
    Product Code
    GXD
    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
    GXD Generator, Lesion, Radiofrequency

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