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510(k) Data Aggregation

    K Number
    K071446
    Device Name
    ELECTRODE ARRAY CAP
    Manufacturer
    ELECTRODE ARRAYS
    Date Cleared
    2008-07-02

    (405 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELECTRODE ARRAYS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electrode Arrays Cap is intended for routine clinical settings where rapid placement of large number or EEG electrodes is desired.
    Device Description
    The Electrode Array Cap comprises an electrode placement system for positioning electrodes. The density of electrodes will vary, but in general will conform to the 10-20 to 5-5 positioning system (Oostenveld & Praamstra, 2005). The electrode will be compatible with all standard AC/DC EEG amplifiers The Electrode Array Cap will consist of an elastic can, electrode holders, sintered Ag/AgCl electrodes, and shielded wires. The Electrode Array Cap will fit all head shapes and will be comfortable to wear. Shielded wires will terminate into a standardized connector designed. Separate shielded cables, tailored to each amplifier system, will mate with the standardized cap connector. Located in each connector will be a passive memory chip that will read out the serial number and other device information.
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