Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213170
    Device Name
    SENSOSEEG Depth Electrodes
    Manufacturer
    Sensomedical Labs LTD
    Date Cleared
    2023-04-18

    (567 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sensomedical Labs LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Senso Medical Depth Electrodes are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
    Device Description
    The SENSO SEEG Electrode is a smooth electrode with a diameter of 0.8 - 2 mm with a rounded tip. Different configurations exist with diameters of 0.8, 1.1, 1.27, and 2.0 mm. The electrode contacts are made from stainless-steel that can be 1.5mm, 2.0, and 3.0 mm long, with a total exploration length varying from (22 - 82 mm) according to the electrode reference. The total length of the electrodes range from 360 mm to 410 mm long depending on the number of contacts and total exploration length of the electrodes. The electrodes come in 3 main configurations, but can be customized to the parameters mentioned above based on the application need.
    Ask a Question

    Page 1 of 1