FDA 510(k)

Carriere Motion Clear Class II

K号: K160720 · 2016-11-28

决定日期2016-11-28

产品代码DYW

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决定实质等同

器械摘要

Carriere Motion Clear Class II is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Organizers, Inc.. It received FDA 510(k) clearance on 2016-11-28 under 510(k) number K160720. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Carriere Motion Clear Class II?

Carriere Motion Clear Class II is a medical device that received FDA 510(k) clearance on 2016-11-28. The listed applicant is Ortho Organizers, Inc.. The 510(k) number is K160720.

When did Carriere Motion Clear Class II receive FDA 510(k) clearance?

Carriere Motion Clear Class II received FDA 510(k) clearance on 2016-11-28, under 510(k) number K160720.

Who is the listed applicant for Carriere Motion Clear Class II?

The FDA 510(k) record lists Ortho Organizers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Carriere Motion Clear Class II?

The FDA product code for Carriere Motion Clear Class II is DYW.

列明Ortho Organizers, Inc.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。

K252760Carriere® Motion Pro® Clear Bite Corrector K173440Carriere SLX 3D Clear

官方来源

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