BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Maxxi Position Sensor

    K Number: K191492 · Decision Apr 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    188
    Applicant Total
    8
    Review Days
    324

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    Basic Information

    Device Name
    Maxxi Position Sensor
    K Number
    K191492
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neurovirtual USA, Inc.
    Date Received
    June 5, 2019
    Decision Date
    April 24, 2020
    Product Code
    GWQ
    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
    GWQ Full-Montage Standard Electroencephalograph

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