FDA 510(k)

HANAROCare ReJu

K号: K160893 · 2016-07-27

决定日期2016-07-27

产品代码NUH

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决定实质等同

器械摘要

HANAROCare ReJu is the device name listed in this FDA 510(k) record. The listed applicant is M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2016-07-27 under 510(k) number K160893. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HANAROCare ReJu?

HANAROCare ReJu is a medical device that received FDA 510(k) clearance on 2016-07-27. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K160893.

When did HANAROCare ReJu receive FDA 510(k) clearance?

HANAROCare ReJu received FDA 510(k) clearance on 2016-07-27, under 510(k) number K160893.

Who is the listed applicant for HANAROCare ReJu?

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

What is the FDA product code for HANAROCare ReJu?

The FDA product code for HANAROCare ReJu is NUH.

列明M.I.Tech 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。

K253327HANAROSTENT 食管上段 (CCC)K213251HANAROSTENT 食管非对称 (CCC)K201160HANAROSTENT 食管 (CCC), HANAROSTENT 食管 (NCN)K202973HANAROSTENT Benefit Biliary (NNN)K201342HANAROSTENT 气管/支气管 (CCC)K200860HANAROSTENT 食管TTS (CCC), HANAROSTENT 食管TTS (NCN)

查看所有 11 个设备 →

相关器械（代码：NUH）

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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