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FDA 510(k)

根尖定位器

K号: K212178 · 2022-07-20

决定日期2022-07-20
产品代码LQY
决定实质等同

器械摘要

Root Apex Locator 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 2022-07-20 under 510(k) number K212178. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

常见问题

What is the Root Apex Locator?

Root Apex Locator is a medical device that received FDA 510(k) clearance on 2022-07-20. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. The 510(k) number is K212178.

When did Root Apex Locator receive FDA 510(k) clearance?

Root Apex Locator received FDA 510(k) clearance on 2022-07-20, under 510(k) number K212178.

Who is the listed applicant for Root Apex Locator?

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 Root Apex Locator?

The FDA product code for Root Apex Locator is LQY.

相关临床试验

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列明Foshan Coxo Medical Instrument Co., Ltd.为申报人的其他记录

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相关器械(代码:LQY)

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。

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