FDA 510(k)

ROSA BRAIN (v3.0.0.5)

K号: K172444 · 2018-03-28

决定日期2018-03-28

产品代码HAW

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决定实质等同

器械摘要

ROSA BRAIN (v3.0.0.5) is the device name listed in this FDA 510(k) record. The listed applicant is Medtech S.A. It received FDA 510(k) clearance on 2018-03-28 under 510(k) number K172444. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ROSA BRAIN (v3.0.0.5)?

ROSA BRAIN (v3.0.0.5) is a medical device that received FDA 510(k) clearance on 2018-03-28. The listed applicant is Medtech S.A. The 510(k) number is K172444.

When did ROSA BRAIN (v3.0.0.5) receive FDA 510(k) clearance?

ROSA BRAIN (v3.0.0.5) received FDA 510(k) clearance on 2018-03-28, under 510(k) number K172444.

Who is the listed applicant for ROSA BRAIN (v3.0.0.5)?

The FDA 510(k) record lists Medtech S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROSA BRAIN (v3.0.0.5)?

The FDA product code for ROSA BRAIN (v3.0.0.5) is HAW.

列明Medtech S.A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。

K200511ROSA ONE脑应用 K192173ROSA ONE 脊柱应用 K182848ROSA ONE 脊柱应用 K182417ROSA ONE脑应用 K151511ROSA 脊柱

官方来源

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