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510(k) Data Aggregation
K Number
K071446Device Name
ELECTRODE ARRAY CAP
Manufacturer
ELECTRODE ARRAYS
Date Cleared
2008-07-02
(405 days)
Product Code
GXY
Regulation Number
882.1320Why 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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