FDA 510(k)

视界2系统

K号: K210109 · 2022-04-08

申请人Eemagine Medical Imaging Solutions GmbH

决定日期2022-04-08

产品代码HAW

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决定实质等同

器械摘要

visor2 system is the device name listed in this FDA 510(k) record. The listed applicant is Eemagine Medical Imaging Solutions GmbH. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K210109. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the visor2 system?

visor2 system is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is Eemagine Medical Imaging Solutions GmbH. The 510(k) number is K210109.

When did visor2 system receive FDA 510(k) clearance?

visor2 system received FDA 510(k) clearance on 2022-04-08, under 510(k) number K210109.

Who is the listed applicant for visor2 system?

The FDA 510(k) record lists Eemagine Medical Imaging Solutions GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for visor2 system?

The FDA product code for visor2 system is HAW.

列明Eemagine Medical Imaging Solutions GmbH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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官方来源

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