FDA 510(k)

EZstim*III Peripheral Nerve Stimulator/Nerve Locator

Номер K: K162048 · 2016-12-05

Дата решения2016-12-05

Код продуктаKOI

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

EZstim*III Peripheral Nerve Stimulator/Nerve Locator is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health - Irvine. It received FDA 510(k) clearance on 2016-12-05 under 510(k) number K162048. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the EZstim*III Peripheral Nerve Stimulator/Nerve Locator?

EZstim*III Peripheral Nerve Stimulator/Nerve Locator is a medical device that received FDA 510(k) clearance on 2016-12-05. The listed applicant is Halyard Health - Irvine. The 510(k) number is K162048.

When did EZstim*III Peripheral Nerve Stimulator/Nerve Locator receive FDA 510(k) clearance?

EZstim*III Peripheral Nerve Stimulator/Nerve Locator received FDA 510(k) clearance on 2016-12-05, under 510(k) number K162048.

Who is the listed applicant for EZstim*III Peripheral Nerve Stimulator/Nerve Locator?

The FDA 510(k) record lists Halyard Health - Irvine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZstim*III Peripheral Nerve Stimulator/Nerve Locator?

The FDA product code for EZstim*III Peripheral Nerve Stimulator/Nerve Locator is KOI.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: KOI)

K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)Senzime AB K250887Neuromuscular Transmission Monitor TOF3D (2510091)MIPM Mammendorfer Institut für Physik und Medizin GmbH K243339WiTOFIdmed K242525iTOF®Nerbio Medical Software Platforms, Inc.K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB K220976Life Scope PT BSM-1700 Series Bedside MonitorNihon Kohden Corporation

Официальный источник

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