Bruxor
K号: K172452 · 2018-01-11
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器械摘要
Bruxor is the device name listed in this FDA 510(k) record. The listed applicant is Sleep Specialties, LLC. It received FDA 510(k) clearance on 2018-01-11 under 510(k) number K172452. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
What is the Bruxor?
Bruxor is a medical device that received FDA 510(k) clearance on 2018-01-11. The listed applicant is Sleep Specialties, LLC. The 510(k) number is K172452.
When did Bruxor receive FDA 510(k) clearance?
Bruxor received FDA 510(k) clearance on 2018-01-11, under 510(k) number K172452.
Who is the listed applicant for Bruxor?
The FDA 510(k) record lists Sleep Specialties, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bruxor?
The FDA product code for Bruxor is OBR. This falls under the Orthopedic category.
相关临床试验
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相关器械（代码：OBR）
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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