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510(k) Data Aggregation

    K Number
    K211315
    Device Name
    Comby EEG Caps
    Manufacturer
    Date Cleared
    2021-11-09

    (193 days)

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

    Pamel d.o.o

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Comby EEG Cap is intended for use in routine clinical settings where rapid placement of large number of EEG electrodes is desired.
    Device Description
    The Comby EEG Cap is an electrode positioning system used to quickly place the standard 20 EEG electrodes or more in a uniform and consistent manner on the head and body in order to transmit electrophysiological signals from an individual to data collection devices. The Comby EEG Cap is made from high quality profile rubber net, electrode plastic holders made of SEBS and electrodes. Electrodes is made of two different conductors, sintered Ag/AgCl and gold coated plates. The EEG Comby Cap is fixed by Velcro tape holders which are fastened beneath the chin of the tested person. The cap holders is fixed to a belt, placed beneath the arms and around the chest of the tested person. The high quality profile rubber net holds the electrodes securely in position during the EEG recording. Wires are attached to each electrode and exit the cap to form a cable, which is used to connect the cap to the EEG equipment, either through an adapter cable, or directly to the equipment with the 25-pin D-sub connector. The electrical activity of the brain is transferred through the conductive Electro-Gel/paste to the recessed electrode and then to the EEG or computer equipment for evaluation. The electrodes on the standard caps are positioned in accordance with the International 10-20 System of electrode placement. In addition, the Comby EEG Cap with as few as 2 to as many as 64 electrodes. Comby EEG are also produced based on customer specified electrode placements, with electrodes made of Ag/AgC1 material. Customized wiring and connectors offer additional options.
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