FDA 510(k)

定制隐形正畸器

K号: K203624 · 2022-06-16

申请人Zhejiang Yinchili Medical Technology Co., Ltd.

决定日期2022-06-16

产品代码NXC

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决定实质等同

器械摘要

Custom-made Invisible Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Yinchili Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K203624. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Custom-made Invisible Aligners?

Custom-made Invisible Aligners is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Zhejiang Yinchili Medical Technology Co., Ltd.. The 510(k) number is K203624.

When did Custom-made Invisible Aligners receive FDA 510(k) clearance?

Custom-made Invisible Aligners received FDA 510(k) clearance on 2022-06-16, under 510(k) number K203624.

Who is the listed applicant for Custom-made Invisible Aligners?

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

What is the FDA product code for Custom-made Invisible Aligners?

The FDA product code for Custom-made Invisible Aligners is NXC.

列明Zhejiang Yinchili Medical Technology Co., Ltd.为申报人的其他记录

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K223454定制隐形正畸器

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