FDA 510(k)

C.A.R.E. 设备（DNA，mRNA，mmRNA）

K号: K230947 · 2023-11-28

决定日期2023-11-28

产品代码LRK

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决定实质等同

器械摘要

C.A.R.E. Appliance (DNA, mRNA, mmRNA) 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 2023-11-28 under 510(k) number K230947. 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 C.A.R.E. Appliance (DNA, mRNA, mmRNA)?

C.A.R.E. Appliance (DNA, mRNA, mmRNA) is a medical device that received FDA 510(k) clearance on 2023-11-28. The listed applicant is Vivos Therapeutics, Inc.. The 510(k) number is K230947.

When did C.A.R.E. Appliance (DNA, mRNA, mmRNA) receive FDA 510(k) clearance?

C.A.R.E. Appliance (DNA, mRNA, mmRNA) received FDA 510(k) clearance on 2023-11-28, under 510(k) number K230947.

Who is the listed applicant for C.A.R.E. Appliance (DNA, mRNA, mmRNA)?

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 C.A.R.E. Appliance (DNA, mRNA, mmRNA)?

The FDA product code for C.A.R.E. Appliance (DNA, mRNA, mmRNA) 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。

K222872DNA矫正器

官方来源

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