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510(k) Data Aggregation
K Number
K162048Device Name
EZstim*III Peripheral Nerve Stimulator/Nerve Locator
Manufacturer
HALYARD HEALTH - IRVINE
Date Cleared
2016-12-05
(133 days)
Product Code
KOI
Regulation Number
868.2775Why 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.
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