FDA 510(k)

AmCAD-UT

K号: K203555 · 2021-09-08

决定日期2021-09-08

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Amcad Biomed Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K180867AmCAD-UO K180006AmCAD-UT Detection 2.2 K162574AmCAD-US K170069AmCAD-UV

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。