i-Rapha解决方案
K号: K201296 · 2020-07-09
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器械摘要
i-Rapha Solution is the device name listed in this FDA 510(k) record. The listed applicant is Irm, Inc.. It received FDA 510(k) clearance on 2020-07-09 under 510(k) number K201296. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the i-Rapha Solution?
i-Rapha Solution is a medical device that received FDA 510(k) clearance on 2020-07-09. The listed applicant is Irm, Inc.. The 510(k) number is K201296.
When did i-Rapha Solution receive FDA 510(k) clearance?
i-Rapha Solution received FDA 510(k) clearance on 2020-07-09, under 510(k) number K201296.
Who is the listed applicant for i-Rapha Solution?
The FDA 510(k) record lists Irm, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for i-Rapha Solution?
The FDA product code for i-Rapha Solution is LLZ.
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相关器械（代码：LLZ）
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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