Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K162048
    Device Name
    EZstim*III Peripheral Nerve Stimulator/Nerve Locator
    Manufacturer
    HALYARD HEALTH - IRVINE
    Date Cleared
    2016-12-05

    (133 days)

    Product Code
    KOI
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    HALYARD HEALTH - IRVINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EZstim*III is a battery powered Peripheral Nerve Stimulator/Nerve Locator with two (2) indications for use: (1) on the high (0.05 - 80 mA) output current range, the device is used to monitor the effects of skeletal muscle relaxants during general anesthesia. (2) on the low (0.05-5.0 mA) output current range, it is used as a Nerve Locator to help locate the tip of a hypodermic needle near the nerve to which local anesthesia is to be delivered in Regional Nerve Block procedures.
    Device Description
    The EZstim* III (Model ES500) is both a constant current Peripheral Nerve Stimulator (HIGH output current range) and a Peripheral Nerve Locator (LOW output current range). Output current range is determined by the model of patient lead cable connected to the unit. - . When the Halyard NSL-5 patient lead cable is connected, the unit automatically sets to the HIGH output current range (0.05 to 80 mA), with no stimulus mode selected (null mode). When the user selects a stimulus mode (i.e., 1 or 2 Hz Twitch, 50 Hz Tetanus, 100 Hz Tetanus, Double-Burst, or Train-of-Four), the unit functions as a nerve stimulator for use in monitoring the effects of skeletal muscle relaxants on the neuromuscular junction. - . When the Halyard RBW-5U patient lead cable is connected, the unit automatically sets to the LOW output current range (0.05 to 5.0 mA). In this range, the unit functions as a nerve locator for use in regional nerve block procedures.
    Ask a Question

    Page 1 of 1