Aniti-Snore Mouthguard+
K号: K231138 · 2024-01-16
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申请人Oscimed SA
决定日期2024-01-16
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
Aniti-Snore Mouthguard+ is the device name listed in this FDA 510(k) record. The listed applicant is Oscimed SA. It received FDA 510(k) clearance on 2024-01-16 under 510(k) number K231138. 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 Aniti-Snore Mouthguard+?
Aniti-Snore Mouthguard+ is a medical device that received FDA 510(k) clearance on 2024-01-16. The listed applicant is Oscimed SA. The 510(k) number is K231138.
When did Aniti-Snore Mouthguard+ receive FDA 510(k) clearance?
Aniti-Snore Mouthguard+ received FDA 510(k) clearance on 2024-01-16, under 510(k) number K231138.
Who is the listed applicant for Aniti-Snore Mouthguard+?
The FDA 510(k) record lists Oscimed SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aniti-Snore Mouthguard+?
The FDA product code for Aniti-Snore Mouthguard+ 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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