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FDA 510(k)

Amydi-med 一次性非侵入性脑电图电极

K号: K240668 · 2024-03-19

申请人Shenzhen Amydi-Med Electrics Tech Co., Ltd.
决定日期2024-03-19
产品代码GXY
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决定实质等同

器械摘要

Amydi-med Disposable Non-invasive EEG electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Amydi-Med Electrics Tech Co., Ltd.. It received FDA 510(k) clearance on 2024-03-19 under 510(k) number K240668. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Amydi-med Disposable Non-invasive EEG electrodes?

Amydi-med Disposable Non-invasive EEG electrodes is a medical device that received FDA 510(k) clearance on 2024-03-19. The listed applicant is Shenzhen Amydi-Med Electrics Tech Co., Ltd.. The 510(k) number is K240668.

When did Amydi-med Disposable Non-invasive EEG electrodes receive FDA 510(k) clearance?

Amydi-med Disposable Non-invasive EEG electrodes received FDA 510(k) clearance on 2024-03-19, under 510(k) number K240668.

Who is the listed applicant for Amydi-med Disposable Non-invasive EEG electrodes?

The FDA 510(k) record lists Shenzhen Amydi-Med Electrics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Amydi-med Disposable Non-invasive EEG electrodes?

The FDA product code for Amydi-med Disposable Non-invasive EEG electrodes is GXY.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：GXY）

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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