FDA 510(k)

ROSA夹具

K号: K182672 · 2019-11-15

决定日期2019-11-15

产品代码NJM

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决定实质等同

器械摘要

ROSA Bracket is the device name listed in this FDA 510(k) record. The listed applicant is Gni Co., Ltd.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K182672. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ROSA Bracket?

ROSA Bracket is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Gni Co., Ltd.. The 510(k) number is K182672.

When did ROSA Bracket receive FDA 510(k) clearance?

ROSA Bracket received FDA 510(k) clearance on 2019-11-15, under 510(k) number K182672.

Who is the listed applicant for ROSA Bracket?

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

What is the FDA product code for ROSA Bracket?

The FDA product code for ROSA Bracket is NJM.

列明Gni 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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