FDA 510(k)

qER-Quant

K号: K211222 · 2021-07-30

决定日期2021-07-30

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

qER-Quant is the device name listed in this FDA 510(k) record. The listed applicant is Qure.Ai Technologies. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K211222. 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 qER-Quant?

qER-Quant is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Qure.Ai Technologies. The 510(k) number is K211222.

When did qER-Quant receive FDA 510(k) clearance?

qER-Quant received FDA 510(k) clearance on 2021-07-30, under 510(k) number K211222.

Who is the listed applicant for qER-Quant?

The FDA 510(k) record lists Qure.Ai Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for qER-Quant?

The FDA product code for qER-Quant is QIH.

列明Qure.Ai Technologies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。

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官方来源

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