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GWN — Nystagmograph Class II

FDA Device Classification

Classification Details

Product Code
GWN
Device Class
Class II
Regulation Number
882.1460
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243709neuroearsNeuroEars-Anna™August 25, 2025
K242198natus medical denmark apsICS Dizcovery (1091)February 14, 2025
K242726inventisSynapsys VHITJanuary 3, 2025
K223047neurobit technologies coNeuroSwift ProJune 29, 2023
K203082vestibular firstInsight Infrared Video GogglesNovember 12, 2020
K200534interacousticsVisualEyesAugust 12, 2020
K192186neurolign usaI-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-PorNovember 29, 2019
K181771righteyeRightEye Vision SystemSeptember 28, 2018
K182214dizzydoctor systemsDizzyDoctor System 1.0.0September 14, 2018
K181025neuro kineticsI-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-PorJuly 24, 2018
K171884neuro kineticsI-Portal Portable Assessment System - Nystagmograph (I-PAS)November 22, 2017
K163270isent tech and trading companyISEN-Goggles with Data ViewerSeptember 25, 2017
K163149interacousticsVisualEyesApril 26, 2017
K163558synapsysSynapsys Ulmer Video NystagmographMarch 23, 2017
K152727isen tech and trading companyISEN-GogglesApril 26, 2016
K152915syncthinkEYE-SYNCJanuary 29, 2016
K152112interacousticsVisualEyesDecember 29, 2015
K151504gn otometricsICS ImpulseNovember 16, 2015
K143607neuro kineticsI-Portal NOTC, VNG and VOGJuly 8, 2015
K131681interacousticsEYESEECAM VHITSeptember 6, 2013