FDA 510(k)

心電圖電纜/導電線

K 號：K172797 · 2018-02-28

決定日期2018-02-28

產品代碼DSA

諮詢委員會履歷

決定相當於

器材摘要

ECG Cable/Leadwires is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Coreray Technology, Ltd.. It received FDA 510(k) clearance on 2018-02-28 under 510(k) number K172797. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ECG Cable/Leadwires?

ECG Cable/Leadwires is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Shenzhen Coreray Technology, Ltd.. The 510(k) number is K172797.

When did ECG Cable/Leadwires receive FDA 510(k) clearance?

ECG Cable/Leadwires received FDA 510(k) clearance on 2018-02-28, under 510(k) number K172797.

Who is the listed applicant for ECG Cable/Leadwires?

The FDA 510(k) record lists Shenzhen Coreray Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG Cable/Leadwires?

The FDA product code for ECG Cable/Leadwires is DSA.

其他以 Shenzhen Coreray Technology, Ltd. 為申請人之記錄

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相關器械（代碼：DSA）

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