BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)

    K Number: K233985 · Decision May 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    149

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    Basic Information

    Device Name
    TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)
    K Number
    K233985
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Megin OY
    Date Received
    December 18, 2023
    Decision Date
    May 15, 2024
    Product Code
    OLX
    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
    OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph

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