FDA 510(k)

Essenz HLM

K 號：K221373 · 2023-03-09

決定日期2023-03-09

產品代碼DTQ

諮詢委員會履歷

決定相當於

器材摘要

Essenz HLM 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 2023-03-09 under 510(k) number K221373. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Essenz HLM?

Essenz HLM is a medical device that received FDA 510(k) clearance on 2023-03-09. The listed applicant is Livanova Deutschland, GmbH. The 510(k) number is K221373.

When did Essenz HLM receive FDA 510(k) clearance?

Essenz HLM received FDA 510(k) clearance on 2023-03-09, under 510(k) number K221373.

Who is the listed applicant for Essenz HLM?

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 HLM?

The FDA product code for Essenz HLM is DTQ.

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 K220635加熱冷卻系統 3T K212003ESSENZ 患者監護儀 K210130Stockert S5 系統 K202154B-Capta K191402加熱冷卻系統 3T

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相關器械（代碼：DTQ）

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 ILBMLivanova Deutschland, GmbH K221895特魯美先進灌流系統 1Terumo Cardiovascular Systems Corporation K210130Stockert S5 系統Livanova Deutschland, GmbH K202125世紀灌流系統Century Hlm, LLC K190282量子智慧閉塞器 LH（左手），量子智慧閉塞器 LH（右手）Spectrum Medical , Ltd.K173834量子泵控制台Spectrum Medical , Ltd.

官方來源

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