FDA 510(k)

I-Portal 便携式评估系统 - 眼震电图（I-PAS）

K号: K171884 · 2017-11-22

决定日期2017-11-22

产品代码GWN

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决定实质等同

器械摘要

I-Portal Portable Assessment System - Nystagmograph (I-PAS) is the device name listed in this FDA 510(k) record. The listed applicant is Neuro Kinetics, Inc.. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K171884. 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 Portable Assessment System - Nystagmograph (I-PAS)?

I-Portal Portable Assessment System - Nystagmograph (I-PAS) is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Neuro Kinetics, Inc.. The 510(k) number is K171884.

When did I-Portal Portable Assessment System - Nystagmograph (I-PAS) receive FDA 510(k) clearance?

I-Portal Portable Assessment System - Nystagmograph (I-PAS) received FDA 510(k) clearance on 2017-11-22, under 510(k) number K171884.

Who is the listed applicant for I-Portal Portable Assessment System - Nystagmograph (I-PAS)?

The FDA 510(k) record lists Neuro Kinetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-Portal Portable Assessment System - Nystagmograph (I-PAS)?

The FDA product code for I-Portal Portable Assessment System - Nystagmograph (I-PAS) is GWN.

列明Neuro Kinetics, Inc.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。

K181025I-Portal 神经耳科测试中心；I-Portal 视频眼震电图系统；I-Portal 视频眼动追踪系统

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