FDA 510(k)

彩虹闪耀

K号: K160079 · 2016-11-10

决定日期2016-11-10

产品代码EIH

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决定实质等同

器械摘要

rainbow Shine is the device name listed in this FDA 510(k) record. The listed applicant is Genoss Co., Ltd.. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K160079. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the rainbow Shine?

rainbow Shine is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K160079.

When did rainbow Shine receive FDA 510(k) clearance?

rainbow Shine received FDA 510(k) clearance on 2016-11-10, under 510(k) number K160079.

Who is the listed applicant for rainbow Shine?

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

What is the FDA product code for rainbow Shine?

The FDA product code for rainbow Shine is EIH.

列明Genoss Co., 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。

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官方来源

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