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

    GSI Audera Pro

    K Number: K193033 · Decision Apr 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    75
    Applicant Total
    1
    Review Days
    176

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    Basic Information

    Device Name
    GSI Audera Pro
    K Number
    K193033
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1900
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Grason Stadler
    Date Received
    October 31, 2019
    Decision Date
    April 24, 2020
    Product Code
    GWJ
    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
    GWJ Stimulator, Auditory, Evoked Response

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