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510(k) Data Aggregation

    K Number
    K964433
    Device Name
    AQUABOND ELECTRODE
    Manufacturer
    Date Cleared
    1997-01-27

    (83 days)

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

    MEDIBOND LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Not Found
    Device Description
    The AQUABOND electrode is a disposable EEG cutaneous electrode that uses an aqueous, conductive adhesive to bond an Ag/AgCl disk to the skin. Because the adhesive is aqueous, removal is quick and unaccompanied by odors from organic solvents, as is the case with electrodes attached with pastes, such as Collodion. The AQUABOND electrode comprises a silver/silver chloride (Ag/AgCI) coated plastic base with an attached aqueous conductive adhesive component. The electrode is supplied in a dry state and when the conductive, adhesive component is wet with common tap water, it becomes sticky and can be attached to the skin, even in locations with hair, to provide a well adhering, low impedance electrode.
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