FDA 510(k)

DNA矫正器

K号: K222872 · 2022-12-30

决定日期2022-12-30

产品代码LRK

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决定实质等同

器械摘要

DNA Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Vivos Therapeutics, Inc.. It received FDA 510(k) clearance on 2022-12-30 under 510(k) number K222872. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DNA Appliance?

DNA Appliance is a medical device that received FDA 510(k) clearance on 2022-12-30. The listed applicant is Vivos Therapeutics, Inc.. The 510(k) number is K222872.

When did DNA Appliance receive FDA 510(k) clearance?

DNA Appliance received FDA 510(k) clearance on 2022-12-30, under 510(k) number K222872.

Who is the listed applicant for DNA Appliance?

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

What is the FDA product code for DNA Appliance?

The FDA product code for DNA Appliance is LRK.

列明Vivos Therapeutics, 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。

K230947C.A.R.E. 设备（DNA，mRNA，mmRNA）

官方来源

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