FDA 510(k)

BR-ABVS 觀察器 1.0

K 號：K151075 · 2016-01-15

決定日期2016-01-15

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

BR-ABVS Viewer 1.0 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 2016-01-15 under 510(k) number K151075. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BR-ABVS Viewer 1.0?

BR-ABVS Viewer 1.0 is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Taihao Medical, Inc.. The 510(k) number is K151075.

When did BR-ABVS Viewer 1.0 receive FDA 510(k) clearance?

BR-ABVS Viewer 1.0 received FDA 510(k) clearance on 2016-01-15, under 510(k) number K151075.

Who is the listed applicant for BR-ABVS Viewer 1.0?

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 BR-ABVS Viewer 1.0?

The FDA product code for BR-ABVS Viewer 1.0 is LLZ.

其他以 Taihao Medical, Inc. 為申請人之記錄

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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