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    K Number
    K011564
    Device Name
    NEOLEAD
    Manufacturer
    NEOTECH PRODUCTS, INC.
    Date Cleared
    2002-01-03

    (227 days)

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

    NEOTECH PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoLead Hydrocolloid/ Hydrogel electrode is intended to be used for resting ECG monitoring on neonatal and pediatric patients in a hospital setting.
    Device Description
    The Neolead is a self-adhesive, disposeable sensor, which receives electrical impulses from the body in a non-invasive manner. These impulses are then transmitted to a monitor, which displays the electrographic patterns of cardiac activity. Hydrogel is the pectin based conductive material between the skin and the sensor. Hydrocolloid is the pectin based adhesive.
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