BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇦🇺 Australia

    Minder System

    K Number: DEN240062 · Decision Apr 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    181

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    Basic Information

    Device Name
    Minder System
    K Number
    DEN240062
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.1360
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Epi-Minder Pty, Ltd.
    Date Received
    October 18, 2024
    Decision Date
    April 17, 2025
    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

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