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510(k) Data Aggregation

    K Number
    K020903
    Device Name
    DOCXS B SERIES ELECTRODES
    Manufacturer
    Date Cleared
    2002-09-26

    (190 days)

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

    DOCXS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Biopotential skin electrodes will be used by the Bio Medical community in both clinical and research applications of the acquisition of all surface biopotentials, standards, and reference, i.e. Electroencephalograph (EEG), Electrocardiograph (ECG), Electromyography (EMG), Electrooculograph (EOG).
    Device Description
    This specific device is comprised of a sintered Ag-AgCl electrode with a 99.99% Silver wire. Some of the electrodes are to be sold as bare electrodes. Some are set and sealed in an epoxy or silicone housing with a PVC, Silicone or other TPE insulated, tinseled copper lead wire attached. The device is then sealed with either silicone or Epoxy. They have a smooth, non-porous finish on all surfaces with no cracks, seams, or bubbles. It is then considered waterproof and cold sterilizable. There is a recess in the underside of the housing surrounding the exposed electrode surface to allow for the placement of an electroconductive gel. The gel establishes contact between the Ag-AgCl electrode and the subject surface to be measured. The gel improves electro conductivity between the subject surface and the Ag-AgCl electrode surface for a more sensitive and accurate reading of the Biopotential. The lead wires are either unterminated or terminate with a 1.5 DIN safety socket, snap, or pinch connector.
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