FDA 510(k)

Artis zee/zeego & Artis Q/Q.zen

K号: K181407 · 2018-08-15

决定日期2018-08-15

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

Artis zee/zeego & Artis Q/Q.zen is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solution USA, Inc.. It received FDA 510(k) clearance on 2018-08-15 under 510(k) number K181407. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Artis zee/zeego & Artis Q/Q.zen?

Artis zee/zeego & Artis Q/Q.zen is a medical device that received FDA 510(k) clearance on 2018-08-15. The listed applicant is Siemens Medical Solution USA, Inc.. The 510(k) number is K181407.

When did Artis zee/zeego & Artis Q/Q.zen receive FDA 510(k) clearance?

Artis zee/zeego & Artis Q/Q.zen received FDA 510(k) clearance on 2018-08-15, under 510(k) number K181407.

Who is the listed applicant for Artis zee/zeego & Artis Q/Q.zen?

The FDA 510(k) record lists Siemens Medical Solution USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Artis zee/zeego & Artis Q/Q.zen?

The FDA product code for Artis zee/zeego & Artis Q/Q.zen is OWB.

列明Siemens Medical Solution USA, Inc.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。

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