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

    EEGER4 MODEL 4.3

    K Number: K122879 · Decision Feb 6, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    171
    Applicant Total
    1
    Review Days
    140

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    Basic Information

    Device Name
    EEGER4 MODEL 4.3
    K Number
    K122879
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eeg Software, LLC
    Date Received
    September 19, 2012
    Decision Date
    February 6, 2013
    Product Code
    HCC
    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
    HCC Device, Biofeedback

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