BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    STELLATE GRIDVIEW

    K Number: K100126 · Decision Dec 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    23
    Applicant Total
    6
    Review Days
    318

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    Basic Information

    Device Name
    STELLATE GRIDVIEW
    K Number
    K100126
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Excel-Tech Ltd. (Xltek)
    Date Received
    January 19, 2010
    Decision Date
    December 3, 2010
    Product Code
    OLX
    Advisory Committee
    Neurology
    Review Advisory Committee
    RA
    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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