Rover
K号: K211423 · 2021-05-21
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器械摘要
Rover is the device name listed in this FDA 510(k) record. The listed applicant is Micro-X Limited. It received FDA 510(k) clearance on 2021-05-21 under 510(k) number K211423. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Rover?
Rover is a medical device that received FDA 510(k) clearance on 2021-05-21. The listed applicant is Micro-X Limited. The 510(k) number is K211423.
When did Rover receive FDA 510(k) clearance?
Rover received FDA 510(k) clearance on 2021-05-21, under 510(k) number K211423.
Who is the listed applicant for Rover?
The FDA 510(k) record lists Micro-X Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rover?
The FDA product code for Rover is IZL.
相关临床试验
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相关器械（代码：IZL）
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。
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官方来源
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