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

    E-EEGX, N-EEGX

    K Number: K191322 · Decision Jan 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    53
    Applicant Total
    30
    Review Days
    252

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    Basic Information

    Device Name
    E-EEGX, N-EEGX
    K Number
    K191322
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GE Healthcare Finland Oy
    Date Received
    May 15, 2019
    Decision Date
    January 22, 2020
    Product Code
    OLT
    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
    OLT Non-Normalizing Quantitative Electroencephalograph Software

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