FDA 510(k)

PrevisEA 裝置

K 號：K211068 · 2021-08-04

決定日期2021-08-04

產品代碼DQD

諮詢委員會履歷

決定相當於

器材摘要

PrevisEA Device is the device name listed in this FDA 510(k) record. The listed applicant is Entac Medical, Inc.. It received FDA 510(k) clearance on 2021-08-04 under 510(k) number K211068. 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 PrevisEA Device?

PrevisEA Device is a medical device that received FDA 510(k) clearance on 2021-08-04. The listed applicant is Entac Medical, Inc.. The 510(k) number is K211068.

When did PrevisEA Device receive FDA 510(k) clearance?

PrevisEA Device received FDA 510(k) clearance on 2021-08-04, under 510(k) number K211068.

Who is the listed applicant for PrevisEA Device?

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

What is the FDA product code for PrevisEA Device?

The FDA product code for PrevisEA Device is DQD.

其他以 Entac Medical, Inc. 為申請人之記錄

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K230769PrevisEA 裝置

相關器械（代碼：DQD）

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