BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    Byteflies Kit

    K Number: K192549 · Decision Jun 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    279

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    Basic Information

    Device Name
    Byteflies Kit
    K Number
    K192549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Byteflies NV
    Date Received
    September 17, 2019
    Decision Date
    June 22, 2020
    Product Code
    OMC
    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
    OMC Reduced- Montage Standard Electroencephalograph

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