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FDA 510(k)

ArtPix Mobile EZ2GO

K号: K162224 · 2016-09-22

决定日期2016-09-22
产品代码KPR
咨询委员会RA
决定实质等同

器械摘要

ArtPix Mobile EZ2GO is the device name listed in this FDA 510(k) record. The listed applicant is Cmt Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K162224. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ArtPix Mobile EZ2GO?

ArtPix Mobile EZ2GO is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Cmt Medical Technologies, Ltd.. The 510(k) number is K162224.

When did ArtPix Mobile EZ2GO receive FDA 510(k) clearance?

ArtPix Mobile EZ2GO received FDA 510(k) clearance on 2016-09-22, under 510(k) number K162224.

Who is the listed applicant for ArtPix Mobile EZ2GO?

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

What is the FDA product code for ArtPix Mobile EZ2GO?

The FDA product code for ArtPix Mobile EZ2GO is KPR.

相关临床试验

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列明Cmt Medical Technologies, Ltd.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。

相关器械(代码:KPR)

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。

官方来源

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