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FDA 510(k)

简单克莱尔

K号: K223278 · 2022-11-17

决定日期2022-11-17
产品代码OHS
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

easy Claire is the device name listed in this FDA 510(k) record. The listed applicant is Y & J Bio Co., Ltd.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K223278. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the easy Claire?

easy Claire is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Y & J Bio Co., Ltd.. The 510(k) number is K223278.

When did easy Claire receive FDA 510(k) clearance?

easy Claire received FDA 510(k) clearance on 2022-11-17, under 510(k) number K223278.

Who is the listed applicant for easy Claire?

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

What is the FDA product code for easy Claire?

The FDA product code for easy Claire is OHS.

相关临床试验

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列明Y & J Bio 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。

相关器械(代码:OHS)

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。

官方来源

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