FDA 510(k)

ECGenius 系統

K 號：K223787 · 2023-08-04

決定日期2023-08-04

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

ECGenius System is the device name listed in this FDA 510(k) record. The listed applicant is Cath Vision Aps. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K223787. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ECGenius System?

ECGenius System is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Cath Vision Aps. The 510(k) number is K223787.

When did ECGenius System receive FDA 510(k) clearance?

ECGenius System received FDA 510(k) clearance on 2023-08-04, under 510(k) number K223787.

Who is the listed applicant for ECGenius System?

The FDA 510(k) record lists Cath Vision Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECGenius System?

The FDA product code for ECGenius System is DQK.

其他以 Cath Vision Aps 為申請人之記錄

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K220306ECGenius 系統

相關器械（代碼：DQK）

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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