FDA 510(k)

維沃系統

K 號：K183710 · 2019-10-04

決定日期2019-10-04

產品代碼DQD

諮詢委員會履歷

決定相當於

器材摘要

Vivio System is the device name listed in this FDA 510(k) record. The listed applicant is Avicena, LLC. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K183710. 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 Vivio System?

Vivio System is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Avicena, LLC. The 510(k) number is K183710.

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

Vivio System received FDA 510(k) clearance on 2019-10-04, under 510(k) number K183710.

Who is the listed applicant for Vivio System?

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

What is the FDA product code for Vivio System?

The FDA product code for Vivio System is DQD.

其他以 Avicena, LLC 為申請人之記錄

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相關器械（代碼：DQD）

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