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510(k) Data Aggregation

    K Number
    K090180
    Device Name
    TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE
    Manufacturer
    Date Cleared
    2009-06-17

    (145 days)

    Product Code
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Tender-Trode® Prewired electrode is a disposable, noninvasive electrode that is intended to be used for resting ECG monitoring on neonatal and pediatric patients in a hospital setting. These electrodes can be used for short-term or long-term applications, up to 24 hours. The Tender-Trode of prewired electrodes are single-use, non-sterile, disposable and are to be used on intact (uninjured) skin.
    Device Description
    A conductive solid gel electrode consisting of a conductive adhesive gel, a silver/silver chloride plated ABS eyelet, an adhesive cloth substrate, vinyl label, 24" wire w/.060 dia. female socket and polystyrene release liner.
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