NightGuard Aire Max
K号: K252698 · 2025-11-03
广告
决定日期2025-11-03
产品代码LRK
咨询委员会DE
请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同
器械摘要
NightGuard Aire Max is the device name listed in this FDA 510(k) record. The listed applicant is Nightguard Express, LLC. It received FDA 510(k) clearance on 2025-11-03 under 510(k) number K252698. 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 NightGuard Aire Max?
NightGuard Aire Max is a medical device that received FDA 510(k) clearance on 2025-11-03. The listed applicant is Nightguard Express, LLC. The 510(k) number is K252698.
When did NightGuard Aire Max receive FDA 510(k) clearance?
NightGuard Aire Max received FDA 510(k) clearance on 2025-11-03, under 510(k) number K252698.
Who is the listed applicant for NightGuard Aire Max?
The FDA 510(k) record lists Nightguard Express, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NightGuard Aire Max?
The FDA product code for NightGuard Aire Max 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。
广告