FDA 510(k)

OPTIMUS CMF 系统

K号: K160363 · 2016-10-20

决定日期2016-10-20

产品代码JEY

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决定实质等同

器械摘要

OPTIMUS CMF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K160363. 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 OPTIMUS CMF SYSTEM?

OPTIMUS CMF SYSTEM is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K160363.

When did OPTIMUS CMF SYSTEM receive FDA 510(k) clearance?

OPTIMUS CMF SYSTEM received FDA 510(k) clearance on 2016-10-20, under 510(k) number K160363.

Who is the listed applicant for OPTIMUS CMF SYSTEM?

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

What is the FDA product code for OPTIMUS CMF SYSTEM?

The FDA product code for OPTIMUS CMF SYSTEM is JEY.

列明Osteonic 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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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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