FDA 510(k)

AmCAD-UT Detection 2.2

K 號：K180006 · 2018-08-31

決定日期2018-08-31

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

AmCAD-UT Detection 2.2 is the device name listed in this FDA 510(k) record. The listed applicant is Amcad Biomed Corporation. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K180006. 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 AmCAD-UT Detection 2.2?

AmCAD-UT Detection 2.2 is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is Amcad Biomed Corporation. The 510(k) number is K180006.

When did AmCAD-UT Detection 2.2 receive FDA 510(k) clearance?

AmCAD-UT Detection 2.2 received FDA 510(k) clearance on 2018-08-31, under 510(k) number K180006.

Who is the listed applicant for AmCAD-UT Detection 2.2?

The FDA 510(k) record lists Amcad Biomed Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AmCAD-UT Detection 2.2?

The FDA product code for AmCAD-UT Detection 2.2 is LLZ.

其他以 Amcad Biomed Corporation 為申請人之記錄

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。

K203555AmCAD-UT K180867AmCAD-UO K162574AmCAD-US K170069AmCAD-UV

相關器械（代碼：LLZ）

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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官方來源

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