FDA 510(k)

MCI-Neuro 固定系统

K号: K212391 · 2022-10-21

决定日期2022-10-21

产品代码GWO

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决定实质等同

器械摘要

MCI-Neuro Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Mci Medical Concept Innovation, Inc.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K212391. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MCI-Neuro Fixation System?

MCI-Neuro Fixation System is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Mci Medical Concept Innovation, Inc.. The 510(k) number is K212391.

When did MCI-Neuro Fixation System receive FDA 510(k) clearance?

MCI-Neuro Fixation System received FDA 510(k) clearance on 2022-10-21, under 510(k) number K212391.

Who is the listed applicant for MCI-Neuro Fixation System?

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

What is the FDA product code for MCI-Neuro Fixation System?

The FDA product code for MCI-Neuro Fixation System is GWO.

列明Mci Medical Concept Innovation, 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。

K182758MCI - CMF 系统

相关器械（代码：GWO）

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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