FDA 510(k)

MCI - CMF 系统

K号: K182758 · 2019-12-05

决定日期2019-12-05

产品代码JEY

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决定实质等同

器械摘要

MCI - CMF 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 2019-12-05 under 510(k) number K182758. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MCI - CMF System?

MCI - CMF System is a medical device that received FDA 510(k) clearance on 2019-12-05. The listed applicant is Mci Medical Concept Innovation, Inc.. The 510(k) number is K182758.

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

MCI - CMF System received FDA 510(k) clearance on 2019-12-05, under 510(k) number K182758.

Who is the listed applicant for MCI - CMF 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 - CMF System?

The FDA product code for MCI - CMF System is JEY.

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。

K212391MCI-Neuro 固定系统

相关器械（代码：JEY）

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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