FDA 510(k)

Argen 清晰正畸器，Argen 清晰正畸器高级版

K号: K192846 · 2020-02-10

决定日期2020-02-10

产品代码NXC

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

Argen Clear Aligner, Argen Clear Aligner Premium is the device name listed in this FDA 510(k) record. The listed applicant is Argen Corporation. It received FDA 510(k) clearance on 2020-02-10 under 510(k) number K192846. 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 Argen Clear Aligner, Argen Clear Aligner Premium?

Argen Clear Aligner, Argen Clear Aligner Premium is a medical device that received FDA 510(k) clearance on 2020-02-10. The listed applicant is Argen Corporation. The 510(k) number is K192846.

When did Argen Clear Aligner, Argen Clear Aligner Premium receive FDA 510(k) clearance?

Argen Clear Aligner, Argen Clear Aligner Premium received FDA 510(k) clearance on 2020-02-10, under 510(k) number K192846.

Who is the listed applicant for Argen Clear Aligner, Argen Clear Aligner Premium?

The FDA 510(k) record lists Argen Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Argen Clear Aligner, Argen Clear Aligner Premium?

The FDA product code for Argen Clear Aligner, Argen Clear Aligner Premium is NXC.

列明Argen Corporation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。

K242458ArgenZ MTZ K183229Argen 清晰正畸器 K172430ArgenIS 钛基托 K160248ArgenIS 钛基托

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。