FDA 510(k)

Neurovision Nerve Locator Monitor (Nerveana), EMGView Software

Номер K: K170677 · 2017-04-05

ЗаявительNeurovision Medical Product, Inc.

Дата решения2017-04-05

Код продуктаGWF

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Neurovision Nerve Locator Monitor (Nerveana), EMGView Software is the device name listed in this FDA 510(k) record. The listed applicant is Neurovision Medical Product, Inc.. It received FDA 510(k) clearance on 2017-04-05 under 510(k) number K170677. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Neurovision Nerve Locator Monitor (Nerveana), EMGView Software?

Neurovision Nerve Locator Monitor (Nerveana), EMGView Software is a medical device that received FDA 510(k) clearance on 2017-04-05. The listed applicant is Neurovision Medical Product, Inc.. The 510(k) number is K170677.

When did Neurovision Nerve Locator Monitor (Nerveana), EMGView Software receive FDA 510(k) clearance?

Neurovision Nerve Locator Monitor (Nerveana), EMGView Software received FDA 510(k) clearance on 2017-04-05, under 510(k) number K170677.

Who is the listed applicant for Neurovision Nerve Locator Monitor (Nerveana), EMGView Software?

The FDA 510(k) record lists Neurovision Medical Product, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neurovision Nerve Locator Monitor (Nerveana), EMGView Software?

The FDA product code for Neurovision Nerve Locator Monitor (Nerveana), EMGView Software is GWF.

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: GWF)

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH K253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology Incorporated K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated K242345Delphi StimulatorQuantalx Neuroscience

Официальный источник

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