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

    E3 and Profile

    K Number: K221471 · Decision Nov 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    48
    Applicant Total
    1
    Review Days
    186

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    Basic Information

    Device Name
    E3 and Profile
    K Number
    K221471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnosys, LLC
    Date Received
    May 20, 2022
    Decision Date
    November 22, 2022
    Product Code
    GWE
    Advisory Committee
    Neurology
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GWE Stimulator, Photic, Evoked Response

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