Fluobeam LX
K号: K190891 · 2019-07-31
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器械摘要
Fluobeam LX is the device name listed in this FDA 510(k) record. The listed applicant is Fluoptics. It received FDA 510(k) clearance on 2019-07-31 under 510(k) number K190891. The device is classified under product code QDG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Fluobeam LX?
Fluobeam LX is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is Fluoptics. The 510(k) number is K190891.
When did Fluobeam LX receive FDA 510(k) clearance?
Fluobeam LX received FDA 510(k) clearance on 2019-07-31, under 510(k) number K190891.
Who is the listed applicant for Fluobeam LX?
The FDA 510(k) record lists Fluoptics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fluobeam LX?
The FDA product code for Fluobeam LX is QDG.
相关临床试验
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相关器械（代码：QDG）
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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