医疗设备监管文本翻译如下： 设备名称：qER 法规要求： 1. 该设备已获得美国食品药品监督管理局（FDA）的批准。 2. 注册编号：510(k) XXXXXXXX 3. 产品上市前批准（PMA）编号：XXXXXXX 4. 临床试验注册编号（NCT）：XXXXXXX 5. 医学文献编号（PMID）：XXXXXXX 6. 设备标识符：XXXXXXX 7. 相关政策：医疗监管政策v1 8. 公司/产品名称：[保留公司/产品名称] 9. 网址：[保留URL]
K号: K200921 · 2020-06-17
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器械摘要
qER 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 2020-06-17 under 510(k) number K200921. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the qER?
qER is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Qure.Ai Technologies. The 510(k) number is K200921.
When did qER receive FDA 510(k) clearance?
qER received FDA 510(k) clearance on 2020-06-17, under 510(k) number K200921.
Who is the listed applicant for qER?
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?
The FDA product code for qER is QAS.
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。
相关器械（代码：QAS）
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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