FDA 510(k)

Nexxis OR, Nexxis

K 號：K170537 · 2017-04-21

決定日期2017-04-21

產品代碼DXJ

諮詢委員會履歷

決定相當於

器材摘要

Nexxis OR, Nexxis is the device name listed in this FDA 510(k) record. The listed applicant is Barco N.V.. It received FDA 510(k) clearance on 2017-04-21 under 510(k) number K170537. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nexxis OR, Nexxis?

Nexxis OR, Nexxis is a medical device that received FDA 510(k) clearance on 2017-04-21. The listed applicant is Barco N.V.. The 510(k) number is K170537.

When did Nexxis OR, Nexxis receive FDA 510(k) clearance?

Nexxis OR, Nexxis received FDA 510(k) clearance on 2017-04-21, under 510(k) number K170537.

Who is the listed applicant for Nexxis OR, Nexxis?

The FDA 510(k) record lists Barco N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nexxis OR, Nexxis?

The FDA product code for Nexxis OR, Nexxis is DXJ.

其他以 Barco N.V. 為申請人之記錄

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相關器械（代碼：DXJ）

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。

K212003ESSENZ 患者監護儀Livanova Deutschland, GmbH K212208飛利浦 IntelliVue 監護軟體（修訂版 E.0X）Philips Medizin Systeme Boeblingen GmbH K201162Essence 55SP 大螢幕系統Shenyang Torch-Bigtide Digital Technology Co., Ltd.K173107Vios中央監控站監控軟體，Vios中央伺服器軟體Vios Medical, Inc.K180534飛利浦 IntelliVue 監護軟體Philips Medizin Systeme Boeblingen GmbH K173381Nexxis ORBarco N.V.

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