FDA 510(k)

NIVR58-T 套件

K 號：K161880 · 2017-03-14

決定日期2017-03-14

產品代碼DXJ

諮詢委員會履歷

決定相當於

器材摘要

NIVR58-T kit 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 2017-03-14 under 510(k) number K161880. 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 NIVR58-T kit?

NIVR58-T kit is a medical device that received FDA 510(k) clearance on 2017-03-14. The listed applicant is Barco N.V.. The 510(k) number is K161880.

When did NIVR58-T kit receive FDA 510(k) clearance?

NIVR58-T kit received FDA 510(k) clearance on 2017-03-14, under 510(k) number K161880.

Who is the listed applicant for NIVR58-T kit?

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 NIVR58-T kit?

The FDA product code for NIVR58-T kit 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.

官方來源

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