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

    GEOSOURCE

    K Number: K092844 · Decision Dec 21, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    23
    Applicant Total
    3
    Review Days
    462

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    Basic Information

    Device Name
    GEOSOURCE
    K Number
    K092844
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Electrical Geodesics, Inc.
    Date Received
    September 15, 2009
    Decision Date
    December 21, 2010
    Product Code
    OLX
    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
    OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph

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    Other Clearances by Electrical Geodesics, Inc.

    K Number Device Name
    K131882 GEODESICEEG SYSTEM 400 SERIES (GES 400)
    K112353 GEODESIC EEG MOBILE 100 (GEM 100)