Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Nystagmograph

FDA product code GWN · 57 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.1460
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1981-08-21 – 2026-07-30

GWN 2026-07-30

SMARTVERTIGO™ Vestibular Assessment System

Applicant VertigoDx, Inc.

K number K260566

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GWN 2025-08-25

NeuroEars-Anna™

Applicant Neuroears, Inc.

K number K243709

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GWN 2025-02-14

ICS Dizcovery (1091)

Applicant Natus Medical Denmark Aps

K number K242198

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GWN 2025-01-03

Synapsys VHIT

Applicant Inventis S.R.L.

K number K242726

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GWN 2023-06-29

NeuroSwift Pro

Applicant Neurobit Technologies Co., Ltd.

K number K223047

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GWN 2020-11-12

Insight Infrared Video Goggles

Applicant Vestibular First

K number K203082

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GWN 2020-08-12

VisualEyes

Applicant Interacoustics A/S

K number K200534

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GWN 2019-11-29

I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph

Applicant Neurolign USA, LLC

K number K192186

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GWN 2018-09-28

RightEye Vision System

Applicant Righteye, LLC

K number K181771

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GWN 2018-09-14

DizzyDoctor System 1.0.0

Applicant Dizzydoctor Systems, LLC

K number K182214

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GWN 2018-07-24

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

Applicant Neuro Kinetics, Inc.

K number K181025

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GWN 2017-11-22

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

Applicant Neuro Kinetics, Inc.

K number K171884

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GWN 2017-09-25

ISEN-Goggles with Data Viewer

Applicant Isent Tech & Trading Company, Ltd.

K number K163270

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GWN 2017-04-26

VisualEyes

Applicant Interacoustics A/S

K number K163149

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GWN 2017-03-23

Synapsys Ulmer Video Nystagmograph

Applicant Synapsys SA

K number K163558

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GWN 2016-04-26

ISEN-Goggles

Applicant Isen Tech & Trading Company, Ltd.

K number K152727

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GWN 2016-01-29

EYE-SYNC

Applicant Syncthink, Inc.

K number K152915

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GWN 2013-09-06

EYESEECAM VHIT

Applicant Interacoustics A/S

K number K131681

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GWN 2013-04-26

NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM

Applicant Ototronix, LLC

K number K130201

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GWN 2013-02-01

ICS IMPULSE

Applicant Gn Otometrics

K number K122550

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GWN 2009-08-06

I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL

Applicant Neuro Kinetics

K number K083603

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GWN 2008-02-05

VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM

Applicant Interacoustics A/S

K number K072254

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GWN 2007-09-18

EYETRACKER/IDEAS

Applicant S.A. Instrumentation Difra

K number K070670

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GWN 2007-03-30

BALANCEBACK MOBILE INTUITIVE VNG SYSTEM

Applicant Fall Prevention Technologies, LLC

K number K070729

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GWN 2006-10-31

CHRONOS VISION EYE TRACKING DEVICE (C-ETD)

Applicant Chronos Vision

K number K062015

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GWN 2006-07-11

FOCUS VNG/ENG TYPE 1068

Applicant Gn Otometrics A/S

K number K061791

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GWN 2005-05-23

DDAT OMT

Applicant Ddat(Uk), Ltd.

K number K050098

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GWN 2004-10-06

BALANCEBACK VNG SYSTEM

Applicant Fall Prevention Technologies, LLC

K number K042529

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GWN 2001-12-10

ICS MEDICAL MODEL VG-30 VIDEO GOGGLES

Applicant Ics Medical

K number K013060

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GWN 2001-02-27

ENGPLUS

Applicant Western Systems Research, Inc.

K number K010059

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GWN 2001-02-01

EYETECT TREMOR MONITOR UNIT (TMU)

Applicant Eyetect, LLC

K number K003644

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GWN 1999-08-12

EXPRESSEYE

Applicant Optomotor Laboratories

K number K992473

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GWN 1999-08-03

EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX

Applicant Bertec Corp.

K number K991642

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GWN 1999-07-28

ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM

Applicant Ics Medical Corp.

K number K991497

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GWN 1998-09-11

ULMER (VNG) VIDEO NYSTAGMOGRAPH

Applicant Synapsys, Inc.

K number K982103

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GWN 1997-09-22

ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER

Applicant Ics Medical Corp.

K number K972631

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GWN 1997-09-10

2D VOG - VIDEO-OCULOGRAPHY

Applicant Sensomotoric Instruments, GmbH

K number K972243

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GWN 1997-07-15

VIDEO EYE TRAKKER

Applicant Micromedical Technologies, Inc.

K number K964646

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GWN 1997-07-15

VISUALEYES: VIDEO EYE MONITOR

Applicant Micromedical Technologies, Inc.

K number K964325

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GWN 1995-02-03

VARIOUS ELECTRODES

Applicant Bio-Logic Systems Corp.

K number K941928

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GWN 1994-12-15

INFRARED EYE MOVEMENT MONITOR

Applicant Microguide, Inc.

K number K926312

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GWN 1994-03-23

HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM

Applicant Eye Dynamics, Inc.

K number K925111

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GWN 1992-06-10

JANUS ATAC ENG ANALYSIS SYSTEM

Applicant Life-Tech Intl., Inc.

K number K904385

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GWN 1988-11-23

NICOLET NYSTAR PLUS SYSTEM

Applicant Nicolet Instrument Corp.

K number K884294

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GWN 1987-07-24

VESTIBULAR AUTOROTATION TEST

Applicant Western Systems Research, Inc.

K number K871466

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GWN 1987-03-23

COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE

Applicant Micromedical Technologies, Inc.

K number K863424

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GWN 1986-04-30

ELECTROCARDIOGRAPH CONTINUOUS MONITOR

Applicant Oxford Medilog, Inc.

K number K860457

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GWN 1985-11-27

NYSTAGMOGRAPH EOG/ENG ANALYSES

Applicant Nicolet Biomedical Instruments

K number K851190

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GWN 1985-07-22

ELECTRONYSTAGMOGRAPH (ENG RECORDER)

Applicant Bio-Logic Systems Corp.

K number K850180

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GWN 1984-12-12

TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL

Applicant Teca, Inc.

K number K842886

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GWN 1984-10-30

SERVO MED NYSTAGMOGRAPH NG-1

Applicant Servo Med, Inc.

K number K843004

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GWN 1984-02-10

PHILLY BOLTS

Applicant Philadelphia Medical Specialties

K number K834148

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GWN 1983-01-28

NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH

Applicant Kelleher Corp.

K number K822268

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GWN 1982-12-22

PHILLY BOLT ADULT PROCEDURE KIT

Applicant Philadelphia Medical Specialties

K number K823459

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GWN 1982-08-16

NAGASHIMA KN-52 SACCADE & PURSUIT STIM

Applicant Kelleher Corp.

K number K822266

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GWN 1982-01-28

PHILLY INFANT BOLT

Applicant Philadelphia Medical Specialties

K number K820151

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GWN 1981-08-21

LIFE-TECH #5102 VISULAB

Applicant Life-Tech Instruments, Inc.

K number K812180

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