FDA 510(k)

高级防打鼾设备4.0透明/高级防打鼾设备4.0蓝色

K号: K250482 · 2025-05-08

决定日期2025-05-08

产品代码LRK

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决定实质等同

器械摘要

Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue is the device name listed in this FDA 510(k) record. The listed applicant is Fissiontech, LLC. It received FDA 510(k) clearance on 2025-05-08 under 510(k) number K250482. 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 Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue?

Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue is a medical device that received FDA 510(k) clearance on 2025-05-08. The listed applicant is Fissiontech, LLC. The 510(k) number is K250482.

When did Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue receive FDA 510(k) clearance?

Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue received FDA 510(k) clearance on 2025-05-08, under 510(k) number K250482.

Who is the listed applicant for Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue?

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 Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue?

The FDA product code for Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue 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 K233850Difiney防打鼾设备

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。