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

    ICS CHARTR EP 200

    K Number: K083399 · Decision Feb 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    75
    Applicant Total
    6
    Review Days
    95

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    Basic Information

    Device Name
    ICS CHARTR EP 200
    K Number
    K083399
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1900
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gn Otometrics A/S
    Date Received
    November 17, 2008
    Decision Date
    February 20, 2009
    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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    Other Clearances by Gn Otometrics A/S

    K Number Device Name
    K143670 ICS CHARTR EP 200 WITH VEMP
    K110286 GN OTOMETRICS TYPE 1053 FREEFIT
    K061791 FOCUS VNG/ENG TYPE 1068
    K061104 SPEECHLINK 100 TYPE 1053
    K033645 OTOFLEX 100 TYE 1012