FDA 510(k)

AmCAD-UT

K 號：K203555 · 2021-09-08

決定日期2021-09-08

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

AmCAD-UT 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 2021-09-08 under 510(k) number K203555. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AmCAD-UT?

AmCAD-UT is a medical device that received FDA 510(k) clearance on 2021-09-08. The listed applicant is Amcad Biomed Corporation. The 510(k) number is K203555.

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

AmCAD-UT received FDA 510(k) clearance on 2021-09-08, under 510(k) number K203555.

Who is the listed applicant for AmCAD-UT?

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?

The FDA product code for AmCAD-UT is QIH.

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。

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相關器械（代碼：QIH）

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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