Us2.v1
K号: K210791 · 2021-07-27
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器械摘要
Us2.v1 is the device name listed in this FDA 510(k) record. The listed applicant is Eko.Ai Pte Ltd. D/B/A Us2.Ai. It received FDA 510(k) clearance on 2021-07-27 under 510(k) number K210791. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Us2.v1?
Us2.v1 is a medical device that received FDA 510(k) clearance on 2021-07-27. The listed applicant is Eko.Ai Pte Ltd. D/B/A Us2.Ai. The 510(k) number is K210791.
When did Us2.v1 receive FDA 510(k) clearance?
Us2.v1 received FDA 510(k) clearance on 2021-07-27, under 510(k) number K210791.
Who is the listed applicant for Us2.v1?
The FDA 510(k) record lists Eko.Ai Pte Ltd. D/B/A Us2.Ai as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Us2.v1?
The FDA product code for Us2.v1 is QIH.
列明Eko.Ai Pte Ltd. D/B/A Us2.Ai为申报人的其他记录
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。
相关器械（代码：QIH）
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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