BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    cortiQ PRO

    K Number: K191432 · Decision Jan 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    240

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    Basic Information

    Device Name
    cortiQ PRO
    K Number
    K191432
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    G.Tec Medical Engineering GmbH
    Date Received
    May 29, 2019
    Decision Date
    January 24, 2020
    Product Code
    OLU
    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
    OLU Normalizing Quantitative Electroencephalograph Software

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