FDA 510(k)

EnVisio導航系統

K 號：K183400 · 2019-03-22

決定日期2019-03-22

產品代碼NEU

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

EnVisio Navigation Sytem is the device name listed in this FDA 510(k) record. The listed applicant is Elucent Medical, Inc.. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K183400. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EnVisio Navigation Sytem?

EnVisio Navigation Sytem is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Elucent Medical, Inc.. The 510(k) number is K183400.

When did EnVisio Navigation Sytem receive FDA 510(k) clearance?

EnVisio Navigation Sytem received FDA 510(k) clearance on 2019-03-22, under 510(k) number K183400.

Who is the listed applicant for EnVisio Navigation Sytem?

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

What is the FDA product code for EnVisio Navigation Sytem?

The FDA product code for EnVisio Navigation Sytem is NEU.

其他以 Elucent Medical, Inc. 為申請人之記錄

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相關器械（代碼：NEU）

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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