BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    UNEEG EpiSight System

    K Number: K253607 · Decision Jun 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    205

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    Basic Information

    Device Name
    UNEEG EpiSight System
    K Number
    K253607
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1360
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uneeg Medical A/S
    Date Received
    November 18, 2025
    Decision Date
    June 11, 2026
    Product Code
    SEM
    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
    SEM Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (SEM), ordered by most recent decision date.

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