FDA 510(k)

Endo超声波激活器

K号: K222096 · 2023-03-23

申请人Foshan Coxo Medical Instrument Co., Ltd.

决定日期2023-03-23

产品代码ELC

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决定实质等同

器械摘要

Endo Ultrasonic Activator is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K222096. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Endo Ultrasonic Activator?

Endo Ultrasonic Activator is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. The 510(k) number is K222096.

When did Endo Ultrasonic Activator receive FDA 510(k) clearance?

Endo Ultrasonic Activator received FDA 510(k) clearance on 2023-03-23, under 510(k) number K222096.

Who is the listed applicant for Endo Ultrasonic Activator?

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

What is the FDA product code for Endo Ultrasonic Activator?

The FDA product code for Endo Ultrasonic Activator is ELC.

列明Foshan Coxo Medical Instrument 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：ELC）

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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