FDA 510(k)

CADence 系統

K 號：K170928 · 2017-08-03

決定日期2017-08-03

產品代碼DQD

諮詢委員會履歷

決定相當於

器材摘要

CADence System is the device name listed in this FDA 510(k) record. The listed applicant is Aum Cardiovascular, Inc.. It received FDA 510(k) clearance on 2017-08-03 under 510(k) number K170928. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CADence System?

CADence System is a medical device that received FDA 510(k) clearance on 2017-08-03. The listed applicant is Aum Cardiovascular, Inc.. The 510(k) number is K170928.

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

CADence System received FDA 510(k) clearance on 2017-08-03, under 510(k) number K170928.

Who is the listed applicant for CADence System?

The FDA 510(k) record lists Aum Cardiovascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CADence System?

The FDA product code for CADence System is DQD.

相關器械（代碼：DQD）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：DQD）

官方來源