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FDA 510(k)

I-Portal 神经耳科测试中心，I-Portal 视频眼震电图系统，I-Portal 便携式评估系统 - 眼震电图

K号: K192186 · 2019-11-29

申请人Neurolign USA, LLC
决定日期2019-11-29
产品代码GWN
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

I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph is the device name listed in this FDA 510(k) record. The listed applicant is Neurolign USA, LLC. It received FDA 510(k) clearance on 2019-11-29 under 510(k) number K192186. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph?

I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph is a medical device that received FDA 510(k) clearance on 2019-11-29. The listed applicant is Neurolign USA, LLC. The 510(k) number is K192186.

When did I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph receive FDA 510(k) clearance?

I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph received FDA 510(k) clearance on 2019-11-29, under 510(k) number K192186.

Who is the listed applicant for I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph?

The FDA 510(k) record lists Neurolign USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph?

The FDA product code for I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph is GWN.

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：GWN）

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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