FDA 510(k)

Artemis, Artemis TPO, Artemis MX

K号: K222222 · 2023-10-12

申请人Eigen

决定日期2023-10-12

产品代码QTZ

咨询委员会RA

决定实质等同

器械摘要

Artemis, Artemis TPO, Artemis MX is the device name listed in this FDA 510(k) record. The listed applicant is Eigen. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K222222. The device is classified under product code QTZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Artemis, Artemis TPO, Artemis MX?

Artemis, Artemis TPO, Artemis MX is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Eigen. The 510(k) number is K222222.

When did Artemis, Artemis TPO, Artemis MX receive FDA 510(k) clearance?

Artemis, Artemis TPO, Artemis MX received FDA 510(k) clearance on 2023-10-12, under 510(k) number K222222.

Who is the listed applicant for Artemis, Artemis TPO, Artemis MX?

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

What is the FDA product code for Artemis, Artemis TPO, Artemis MX?

The FDA product code for Artemis, Artemis TPO, Artemis MX is QTZ.

列明Eigen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。

K173744ProFuse CAD K162474Artemis

官方来源

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