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FDA 510(k)

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

K-Number: K181025 · 2018-07-24

ApplicantNeuro Kinetics, Inc.
Decision Date2018-07-24
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System is a medical device manufactured by Neuro Kinetics, Inc.. It received FDA 510(k) clearance on 2018-07-24 under approval number K181025. 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 Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System?

I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System is a medical device that received FDA 510(k) clearance on 2018-07-24. It is manufactured by Neuro Kinetics, Inc.. The 510(k) number is K181025.

When was I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System approved by the FDA?

I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System received FDA 510(k) clearance on 2018-07-24, under approval number K181025.

What company makes I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System?

I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System is manufactured by Neuro Kinetics, Inc..

What is the FDA product code for I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System?

The FDA product code for I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System is GWN.

Related Clinical Trials

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Neuro Kinetics, Inc.

K171884I-Portal Portable Assessment System - Nystagmograph (I-PAS)

Related Devices (Code: GWN)

K152727ISEN-GogglesIsen Tech & Trading Company, Ltd. K152915EYE-SYNCSyncthink, Inc. K171884I-Portal Portable Assessment System - Nystagmograph (I-PAS)Neuro Kinetics, Inc. K163270ISEN-Goggles with Data ViewerIsent Tech & Trading Company, Ltd. K163149VisualEyesInteracoustics A/S K163558Synapsys Ulmer Video NystagmographSynapsys SA

Official Source

View on FDA Database →

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

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