FDA 510(k)

ESSENZ 患者監護儀

K 號：K212003 · 2021-11-10

決定日期2021-11-10

產品代碼DXJ

諮詢委員會履歷

決定相當於

器材摘要

ESSENZ Patient Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Livanova Deutschland, GmbH. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K212003. 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 ESSENZ Patient Monitor?

ESSENZ Patient Monitor is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Livanova Deutschland, GmbH. The 510(k) number is K212003.

When did ESSENZ Patient Monitor receive FDA 510(k) clearance?

ESSENZ Patient Monitor received FDA 510(k) clearance on 2021-11-10, under 510(k) number K212003.

Who is the listed applicant for ESSENZ Patient Monitor?

The FDA 510(k) record lists Livanova Deutschland, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESSENZ Patient Monitor?

The FDA product code for ESSENZ Patient Monitor is DXJ.

其他以 Livanova Deutschland, GmbH 為申請人之記錄

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。

K232291Essenz HLM, Essenz ILBM K221373Essenz HLM K220635加熱冷卻系統 3T K210130Stockert S5 系統 K202154B-Capta K191402加熱冷卻系統 3T

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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。

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.K172969Essence 55S 大螢幕系統Shenyang Torch-Bigtide Digital Technology Co., Ltd.

官方來源

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