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FDA 510(k)

Neurovision神經定位監視器（Nerveana），EMGView軟體

K 號：K170677 · 2017-04-05

申請人Neurovision Medical Product, Inc.
決定日期2017-04-05
產品代碼GWF
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

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.

常見問題

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.

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相關器械（代碼：GWF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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