Axonpen, Axonmonitor, Axonbox, 平板电脑
K号: K201308 · 2020-11-27
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决定日期2020-11-27
产品代码GWG
咨询委员会NE
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决定实质等同
器械摘要
Axonpen, Axonmonitor, Axonbox, Tablet is the device name listed in this FDA 510(k) record. The listed applicant is Clearmind Biomedical. It received FDA 510(k) clearance on 2020-11-27 under 510(k) number K201308. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Axonpen, Axonmonitor, Axonbox, Tablet?
Axonpen, Axonmonitor, Axonbox, Tablet is a medical device that received FDA 510(k) clearance on 2020-11-27. The listed applicant is Clearmind Biomedical. The 510(k) number is K201308.
When did Axonpen, Axonmonitor, Axonbox, Tablet receive FDA 510(k) clearance?
Axonpen, Axonmonitor, Axonbox, Tablet received FDA 510(k) clearance on 2020-11-27, under 510(k) number K201308.
Who is the listed applicant for Axonpen, Axonmonitor, Axonbox, Tablet?
The FDA 510(k) record lists Clearmind Biomedical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Axonpen, Axonmonitor, Axonbox, Tablet?
The FDA product code for Axonpen, Axonmonitor, Axonbox, Tablet is GWG.
相关临床试验
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列明Clearmind Biomedical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：GWG）
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
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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