FDA 510(k)

Difiney防打鼾设备

K号: K233850 · 2024-04-18

决定日期2024-04-18

产品代码LRK

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决定实质等同

器械摘要

Difiney Anti Snoring Device is the device name listed in this FDA 510(k) record. The listed applicant is Fissiontech, LLC. It received FDA 510(k) clearance on 2024-04-18 under 510(k) number K233850. 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 Difiney Anti Snoring Device?

Difiney Anti Snoring Device is a medical device that received FDA 510(k) clearance on 2024-04-18. The listed applicant is Fissiontech, LLC. The 510(k) number is K233850.

When did Difiney Anti Snoring Device receive FDA 510(k) clearance?

Difiney Anti Snoring Device received FDA 510(k) clearance on 2024-04-18, under 510(k) number K233850.

Who is the listed applicant for Difiney Anti Snoring Device?

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

What is the FDA product code for Difiney Anti Snoring Device?

The FDA product code for Difiney Anti Snoring Device is LRK.

列明Fissiontech, 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。

K253355Difiney高级防打鼾设备4.0 K250482高级防打鼾设备4.0透明/高级防打鼾设备4.0蓝色

官方来源

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