防打鼾口腔器
K号: K250028 · 2025-10-03
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决定日期2025-10-03
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
Anti Snore Mouthpiece is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Yiyao Science & Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K250028. 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 Anti Snore Mouthpiece?
Anti Snore Mouthpiece is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Dongguan Yiyao Science & Technology Development Co., Ltd.. The 510(k) number is K250028.
When did Anti Snore Mouthpiece receive FDA 510(k) clearance?
Anti Snore Mouthpiece received FDA 510(k) clearance on 2025-10-03, under 510(k) number K250028.
Who is the listed applicant for Anti Snore Mouthpiece?
The FDA 510(k) record lists Dongguan Yiyao Science & Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Anti Snore Mouthpiece?
The FDA product code for Anti Snore Mouthpiece 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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