FDA 510(k)

Multi-Link™ X2 心電圖轉接器和導線

K 號：K200510 · 2020-10-09

決定日期2020-10-09

產品代碼DSA

諮詢委員會履歷

決定相當於

器材摘要

Multi-LinkTM X2 ECG Adapter and Leadwires is the device name listed in this FDA 510(k) record. The listed applicant is Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2020-10-09 under 510(k) number K200510. 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 Multi-LinkTM X2 ECG Adapter and Leadwires?

Multi-LinkTM X2 ECG Adapter and Leadwires is a medical device that received FDA 510(k) clearance on 2020-10-09. The listed applicant is Vyaire Medical, Inc.. The 510(k) number is K200510.

When did Multi-LinkTM X2 ECG Adapter and Leadwires receive FDA 510(k) clearance?

Multi-LinkTM X2 ECG Adapter and Leadwires received FDA 510(k) clearance on 2020-10-09, under 510(k) number K200510.

Who is the listed applicant for Multi-LinkTM X2 ECG Adapter and Leadwires?

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

What is the FDA product code for Multi-LinkTM X2 ECG Adapter and Leadwires?

The FDA product code for Multi-LinkTM X2 ECG Adapter and Leadwires is DSA.

其他以 Vyaire Medical, Inc. 為申請人之記錄

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相關器械（代碼：DSA）

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