FDA 510(k)

SleepRight 喉咙呼吸辅助器

K号: K250122 · 2025-05-19

决定日期2025-05-19

产品代码LRK

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决定实质等同

器械摘要

SleepRight Snore Aid is the device name listed in this FDA 510(k) record. The listed applicant is Splintek, Inc.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) number K250122. 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 SleepRight Snore Aid?

SleepRight Snore Aid is a medical device that received FDA 510(k) clearance on 2025-05-19. The listed applicant is Splintek, Inc.. The 510(k) number is K250122.

When did SleepRight Snore Aid receive FDA 510(k) clearance?

SleepRight Snore Aid received FDA 510(k) clearance on 2025-05-19, under 510(k) number K250122.

Who is the listed applicant for SleepRight Snore Aid?

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

What is the FDA product code for SleepRight Snore Aid?

The FDA product code for SleepRight Snore Aid is LRK.

列明Splintek, 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。

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官方来源

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