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FDA 510(k)

BU-CAD

K 號:K210670 · 2021-12-21

決定日期2021-12-21
產品代碼QDQ
諮詢委員會RA
決定相當於

器材摘要

BU-CAD is the device name listed in this FDA 510(k) record. The listed applicant is Taihao Medical, Inc.. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K210670. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BU-CAD?

BU-CAD is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Taihao Medical, Inc.. The 510(k) number is K210670.

When did BU-CAD receive FDA 510(k) clearance?

BU-CAD received FDA 510(k) clearance on 2021-12-21, under 510(k) number K210670.

Who is the listed applicant for BU-CAD?

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

What is the FDA product code for BU-CAD?

The FDA product code for BU-CAD is QDQ.

其他以 Taihao Medical, Inc. 為申請人之記錄

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相關器械(代碼:QDQ)

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官方來源

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