RetinAI Discovery
K号: K211715 · 2022-04-28
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器械摘要
RetinAI Discovery is the device name listed in this FDA 510(k) record. The listed applicant is Retinai Medical AG. It received FDA 510(k) clearance on 2022-04-28 under 510(k) number K211715. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the RetinAI Discovery?
RetinAI Discovery is a medical device that received FDA 510(k) clearance on 2022-04-28. The listed applicant is Retinai Medical AG. The 510(k) number is K211715.
When did RetinAI Discovery receive FDA 510(k) clearance?
RetinAI Discovery received FDA 510(k) clearance on 2022-04-28, under 510(k) number K211715.
Who is the listed applicant for RetinAI Discovery?
The FDA 510(k) record lists Retinai Medical AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RetinAI Discovery?
The FDA product code for RetinAI Discovery is NFJ.
相关临床试验
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相关器械（代码：NFJ）
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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