FDA 510(k)

2430MCA with Xmaru W

K号: K202902 · 2021-06-21

决定日期2021-06-21

产品代码MUE

咨询委员会RA

决定实质等同

器械摘要

2430MCA with Xmaru W is the device name listed in this FDA 510(k) record. The listed applicant is Rayence Co., Ltd.. It received FDA 510(k) clearance on 2021-06-21 under 510(k) number K202902. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 2430MCA with Xmaru W?

2430MCA with Xmaru W is a medical device that received FDA 510(k) clearance on 2021-06-21. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K202902.

When did 2430MCA with Xmaru W receive FDA 510(k) clearance?

2430MCA with Xmaru W received FDA 510(k) clearance on 2021-06-21, under 510(k) number K202902.

Who is the listed applicant for 2430MCA with Xmaru W?

FDA 510(k)记录将Rayence Co., Ltd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for 2430MCA with Xmaru W?

The FDA product code for 2430MCA with Xmaru W is MUE.

列明Rayence 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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