FDA 510(k)

CUSTMBITE打鼾系统

K号: K221322 · 2022-10-27

决定日期2022-10-27

产品代码LRK

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决定实质等同

器械摘要

CUSTMBITE Snoring System is the device name listed in this FDA 510(k) record. The listed applicant is Dental Choice Holdings, LLC. It received FDA 510(k) clearance on 2022-10-27 under 510(k) number K221322. 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 CUSTMBITE Snoring System?

CUSTMBITE Snoring System is a medical device that received FDA 510(k) clearance on 2022-10-27. The listed applicant is Dental Choice Holdings, LLC. The 510(k) number is K221322.

When did CUSTMBITE Snoring System receive FDA 510(k) clearance?

CUSTMBITE Snoring System received FDA 510(k) clearance on 2022-10-27, under 510(k) number K221322.

Who is the listed applicant for CUSTMBITE Snoring System?

The FDA 510(k) record lists Dental Choice Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUSTMBITE Snoring System?

The FDA product code for CUSTMBITE Snoring System is LRK.

列明Dental Choice Holdings, LLC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。

K183315CustMBite 牙齿保护器

官方来源

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