FDA 510(k)

RayCare 2.3

K号: K191384 · 2019-07-08

决定日期2019-07-08

产品代码MUJ

咨询委员会RA

决定实质等同

器械摘要

RayCare 2.3 is the device name listed in this FDA 510(k) record. The listed applicant is RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2019-07-08 under 510(k) number K191384. 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 RayCare 2.3?

RayCare 2.3 is a medical device that received FDA 510(k) clearance on 2019-07-08. The listed applicant is RaySearch Laboratories AB (PUBL). The 510(k) number is K191384.

When did RayCare 2.3 receive FDA 510(k) clearance?

RayCare 2.3 received FDA 510(k) clearance on 2019-07-08, under 510(k) number K191384.

Who is the listed applicant for RayCare 2.3?

The FDA 510(k) record lists RaySearch Laboratories AB (PUBL) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RayCare 2.3?

The FDA product code for RayCare 2.3 is MUJ.

列明RaySearch Laboratories AB (PUBL)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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