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FDA 510(k)

I-Portal Portable Assessment System - Nystagmograph (I-PAS)

K-Number: K171884 · 2017-11-22

ApplicantNeuro Kinetics, Inc.
Decision Date2017-11-22
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Neuro Kinetics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181025I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System

Related Devices (Code: GWN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260566SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc.K243709NeuroEars-Anna™Neuroears, Inc.K242198ICS Dizcovery (1091)Natus Medical Denmark ApsK242726Synapsys VHITInventis S.R.L.K223047NeuroSwift ProNeurobit Technologies Co., Ltd.K203082Insight Infrared Video GogglesVestibular First

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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