FDA 510(k)

Radiance V3

K号: K153368 · 2016-02-16

申请人Gmv Soluciones Globales Internet S.A.U.

决定日期2016-02-16

产品代码MUJ

咨询委员会RA

决定实质等同

器械摘要

Radiance V3 is the device name listed in this FDA 510(k) record. The listed applicant is Gmv Soluciones Globales Internet S.A.U.. It received FDA 510(k) clearance on 2016-02-16 under 510(k) number K153368. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Radiance V3?

Radiance V3 is a medical device that received FDA 510(k) clearance on 2016-02-16. The listed applicant is Gmv Soluciones Globales Internet S.A.U.. The 510(k) number is K153368.

When did Radiance V3 receive FDA 510(k) clearance?

Radiance V3 received FDA 510(k) clearance on 2016-02-16, under 510(k) number K153368.

Who is the listed applicant for Radiance V3?

The FDA 510(k) record lists Gmv Soluciones Globales Internet S.A.U. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radiance V3?

The FDA product code for Radiance V3 is MUJ.

列明Gmv Soluciones Globales Internet S.A.U.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。

K233236Radiance V5 K171885Radiance V4

官方来源

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