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510(k) Data Aggregation

    K Number
    K982470
    Device Name
    ECG ELECTRODES APRON
    Manufacturer
    TAPUZ MEDICAL TECHNOLOGY LTD.
    Date Cleared
    1998-10-14

    (90 days)

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

    TAPUZ MEDICAL TECHNOLOGY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ECG Electrodes Apron is a reusable electrode system intended for use in rest ECG recording. The ECG Electrodes Apron is compatible for use with most ECG instruments on the market.
    Device Description
    ECG Electrodes Apron is a system of ECG electrodes cast in a The hyper-flexible silicone apron The electrodes are gold-plated and the conductors are made of copper. The entire apron, including the conductors, is flexible and can be stretched to fit all body shapes and sizes, men and women alike. The apron is connected by a standard cable and is compatible with almost any type of commonly used ECG instrument.
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