NeuroOne 皮层电极
K号: K192764 · 2019-11-26
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决定日期2019-11-26
产品代码GYC
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
NeuroOne Cortical Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Neuroone, Inc.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192764. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NeuroOne Cortical Electrode?
NeuroOne Cortical Electrode is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Neuroone, Inc.. The 510(k) number is K192764.
When did NeuroOne Cortical Electrode receive FDA 510(k) clearance?
NeuroOne Cortical Electrode received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192764.
Who is the listed applicant for NeuroOne Cortical Electrode?
The FDA 510(k) record lists Neuroone, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NeuroOne Cortical Electrode?
The FDA product code for NeuroOne Cortical Electrode is GYC.
相关临床试验
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：GYC）
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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