510(k) K162048

EZstim*III Peripheral Nerve Stimulator/Nerve Locator by Halyard Health - Irvine — Product Code KOI

K162048 is an FDA 510(k) premarket notification submitted by Halyard Health - Irvine for the device "EZstim*III Peripheral Nerve Stimulator/Nerve Locator". The FDA issued a decision of Substantially Equivalent on December 5, 2016. The device falls under product code KOI (Stimulator, Nerve, Peripheral, Electric), a Class II device regulated under 21 CFR 868.2775.