Dormiva 抗打鼾口腔矫正器
K号: K261134 · 2026-05-14
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决定日期2026-05-14
产品代码LRK
咨询委员会DE
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决定实质等同
器械摘要
Dormiva Anti-Snoring Mouth Guard is the device name listed in this FDA 510(k) record. The listed applicant is Koncept Innovators, Inc.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K261134. 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 Dormiva Anti-Snoring Mouth Guard?
Dormiva Anti-Snoring Mouth Guard is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Koncept Innovators, Inc.. The 510(k) number is K261134.
When did Dormiva Anti-Snoring Mouth Guard receive FDA 510(k) clearance?
Dormiva Anti-Snoring Mouth Guard received FDA 510(k) clearance on 2026-05-14, under 510(k) number K261134.
Who is the listed applicant for Dormiva Anti-Snoring Mouth Guard?
The FDA 510(k) record lists Koncept Innovators, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dormiva Anti-Snoring Mouth Guard?
The FDA product code for Dormiva Anti-Snoring Mouth Guard is LRK.
相关临床试验
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。
相关器械（代码：LRK）
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。
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。
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