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

    FREMAP ELECTRODE

    K Number: K152769 · Decision May 6, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    8
    Review Days
    224

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    Basic Information

    Device Name
    FREMAP ELECTRODE
    K Number
    K152769
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ad-Tech Medical Instrument Corporation
    Date Received
    September 25, 2015
    Decision Date
    May 6, 2016
    Product Code
    ETN
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ETN Stimulator, Nerve

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    Other Clearances by Ad-Tech Medical Instrument Corporation

    K Number Device Name
    K223276 Anchor Bolts as Accessories to Depth Electrodes
    K223269 Spencer Probe Depth Electrodes
    K191186 Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
    K181544 Anchor Bolt (as an accessory to Depth Electrodes)
    K170442 Cranial Drill Bits and Accessories
    K163355 Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
    K152547 DNAP Electrode