FDA 510(k)

Monaco RTP系统

K号: K183037 · 2018-12-04

决定日期2018-12-04

产品代码MUJ

咨询委员会RA

决定实质等同

器械摘要

Monaco RTP System is the device name listed in this FDA 510(k) record. The listed applicant is Elekta, Inc.. It received FDA 510(k) clearance on 2018-12-04 under 510(k) number K183037. 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 Monaco RTP System?

Monaco RTP System is a medical device that received FDA 510(k) clearance on 2018-12-04. The listed applicant is Elekta, Inc.. The 510(k) number is K183037.

When did Monaco RTP System receive FDA 510(k) clearance?

Monaco RTP System received FDA 510(k) clearance on 2018-12-04, under 510(k) number K183037.

Who is the listed applicant for Monaco RTP System?

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

What is the FDA product code for Monaco RTP System?

The FDA product code for Monaco RTP System is MUJ.

列明Elekta, Inc.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。

K190178Monaco RTP系统 K183034MOSAIQ肿瘤学信息系统

官方来源

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