FDA 510(k)

心電圖線

K 號：K191428 · 2019-11-27

申請人Shenzhen Changke Connect Electronics Co., Ltd.

決定日期2019-11-27

產品代碼DSA

諮詢委員會履歷

決定相當於

器材摘要

ECG Cable is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changke Connect Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-11-27 under 510(k) number K191428. 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?

ECG Cable is a medical device that received FDA 510(k) clearance on 2019-11-27. The listed applicant is Shenzhen Changke Connect Electronics Co., Ltd.. The 510(k) number is K191428.

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

ECG Cable received FDA 510(k) clearance on 2019-11-27, under 510(k) number K191428.

Who is the listed applicant for ECG Cable?

The FDA 510(k) record lists Shenzhen Changke Connect Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG Cable?

The FDA product code for ECG Cable is DSA.

其他以 Shenzhen Changke Connect Electronics Co., Ltd. 為申請人之記錄

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相關器械（代碼：DSA）

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