BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    DIXI Medical Microdeep Micro-Macro Depth Electrodes

    K Number: K202087 · Decision Nov 18, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    57
    Applicant Total
    3
    Review Days
    478

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    Basic Information

    Device Name
    DIXI Medical Microdeep Micro-Macro Depth Electrodes
    K Number
    K202087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dixi Medical
    Date Received
    July 28, 2020
    Decision Date
    November 18, 2021
    Product Code
    GZL
    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
    GZL Electrode, Depth

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    Other Clearances by Dixi Medical

    K Number Device Name
    K201931 Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
    K170959 DIXI Medical Microdeep Depth Electrode