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510(k) Data Aggregation

    K Number
    K973663
    Device Name
    PALJET-B
    Manufacturer
    GOLDEN GATE BIO-DEVICE
    Date Cleared
    1998-02-10

    (138 days)

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

    GOLDEN GATE BIO-DEVICE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Paljet-B patient cable system is a reusable ECG suction electrode system. It is designed for diagnostic purposes and is compatible with all electrocardiographs on the U.S. market.
    Device Description
    The Paljet-B patient cable system is a reusable ECG suction electrode system. The entire electrode assembly was redesigned using some different materials (these materials never come in contact with the patient and are made of plastic) these provided for a more reliable electrode. Also a safer electrode because of the elimination of any sharp edges on the contact surfaces that came into contact with human skin. Changed from an AC power source to DC power source reduced the weight and eliminated the hanging arm configuration to enhance the portability aspects of the new device. Many changes were made in the mechanical aspects of the machine, however the basic operational aspect of the Paljet is unchanged from the Wavetracer.
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