FDA 510(k)

牙科手柄，型号CA160，CA160L，和CA500L

K号: K220577 · 2022-07-29

决定日期2022-07-29

产品代码EGS

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决定实质等同

器械摘要

Dental Handpiece, Model CA160, CA160L, and CA500L is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Nx Co., Ltd.. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K220577. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dental Handpiece, Model CA160, CA160L, and CA500L?

Dental Handpiece, Model CA160, CA160L, and CA500L is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Micro-Nx Co., Ltd.. The 510(k) number is K220577.

When did Dental Handpiece, Model CA160, CA160L, and CA500L receive FDA 510(k) clearance?

Dental Handpiece, Model CA160, CA160L, and CA500L received FDA 510(k) clearance on 2022-07-29, under 510(k) number K220577.

Who is the listed applicant for Dental Handpiece, Model CA160, CA160L, and CA500L?

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

What is the FDA product code for Dental Handpiece, Model CA160, CA160L, and CA500L?

The FDA product code for Dental Handpiece, Model CA160, CA160L, and CA500L is EGS.

列明Micro-Nx 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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官方来源

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