FDA 510(k)

Essenz HLM, Essenz ILBM

K 號：K232291 · 2023-08-24

決定日期2023-08-24

產品代碼DTQ

諮詢委員會履歷

決定相當於

器材摘要

Essenz HLM, Essenz ILBM 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 2023-08-24 under 510(k) number K232291. 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 ILBM?

Essenz HLM, Essenz ILBM is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Livanova Deutschland, GmbH. The 510(k) number is K232291.

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

Essenz HLM, Essenz ILBM received FDA 510(k) clearance on 2023-08-24, under 510(k) number K232291.

Who is the listed applicant for Essenz HLM, Essenz ILBM?

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, Essenz ILBM?

The FDA product code for Essenz HLM, Essenz ILBM 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。

K221373Essenz HLM 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。

K221895特魯美先進灌流系統 1Terumo Cardiovascular Systems Corporation K221373Essenz HLMLivanova Deutschland, GmbH 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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