Brux 夜间护牙器
K号: K181361 · 2019-04-11
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器械摘要
Brux Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is Brux Night Guard. It received FDA 510(k) clearance on 2019-04-11 under 510(k) number K181361. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.
常见问题
What is the Brux Night Guard?
Brux Night Guard is a medical device that received FDA 510(k) clearance on 2019-04-11. The listed applicant is Brux Night Guard. The 510(k) number is K181361.
When did Brux Night Guard receive FDA 510(k) clearance?
Brux Night Guard received FDA 510(k) clearance on 2019-04-11, under 510(k) number K181361.
Who is the listed applicant for Brux Night Guard?
The FDA 510(k) record lists Brux Night Guard as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Brux Night Guard?
The FDA product code for Brux Night Guard is MQC.
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：MQC）
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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