FDA 510(k)

MR4 激光

K号: K171354 · 2018-01-13

决定日期2018-01-13

产品代码NHN

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决定实质等同

器械摘要

MR4 Laser is the device name listed in this FDA 510(k) record. The listed applicant is Multi Radiance Medical. It received FDA 510(k) clearance on 2018-01-13 under 510(k) number K171354. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MR4 Laser?

MR4 Laser is a medical device that received FDA 510(k) clearance on 2018-01-13. The listed applicant is Multi Radiance Medical. The 510(k) number is K171354.

When did MR4 Laser receive FDA 510(k) clearance?

MR4 Laser received FDA 510(k) clearance on 2018-01-13, under 510(k) number K171354.

Who is the listed applicant for MR4 Laser?

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

What is the FDA product code for MR4 Laser?

The FDA product code for MR4 Laser is NHN.

列明Multi Radiance Medical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。

K212189FibroLux

官方来源

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