FDA 510(k)

ZOLL心律管理系統

K 號：K190939 · 2019-12-19

決定日期2019-12-19

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

ZOLL Arrhythmia Management Sysyem is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Manufacturing Corporation. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K190939. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ZOLL Arrhythmia Management Sysyem?

ZOLL Arrhythmia Management Sysyem is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Zoll Manufacturing Corporation. The 510(k) number is K190939.

When did ZOLL Arrhythmia Management Sysyem receive FDA 510(k) clearance?

ZOLL Arrhythmia Management Sysyem received FDA 510(k) clearance on 2019-12-19, under 510(k) number K190939.

Who is the listed applicant for ZOLL Arrhythmia Management Sysyem?

The FDA 510(k) record lists Zoll Manufacturing Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZOLL Arrhythmia Management Sysyem?

The FDA product code for ZOLL Arrhythmia Management Sysyem is MHX.

其他以 Zoll Manufacturing Corporation 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。

K182093ZOLL 心電圖分析軟體 K172510µCor 心衰竭與心律不整管理系統

相關器械（代碼：MHX）

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。

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官方來源

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