GWN

Product Code: GWN


Products Classified as GWN

3645NystagmographNystagmograph.

Total Product Life Cycle (TPLC) Devices

3645NystagmographNystagmograph.

FDA Consensus Standards

Nystagmograph [32696]21 CFR §882.1460 🔎

Pre-market Notifications for GWN

K203082Insight Infrared Video GogglesVestibular First
K200534VisualEyesInteracoustics A/S
K192186I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - NysragmographNeurolign USA, LLC
K182214DizzyDoctor System 1.0.0DizzyDoctor Systems, LLC
K181771RightEye Vision SystemRightEye, LLC
K181025I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking SystemNeuro Kinetics, Inc.
K171884I-Portal Portable Assessment System - Nystagmograph (I-PAS)Neuro Kinetics, Inc
K163558Synapsys Ulmer Video NystagmographSynapsys SA
K163270ISEN-Goggles With Data ViewerISENT TECH & TRADING COMPANY,LTD.
K163149VisualEyesInteracoustics A/S
K152915EYE-SYNCSyncThink, Inc.
K152727ISEN-GogglesISEN TECH & TRADING COMPANY, LTD.
K152112VisualEyesINTERACOUSTICS A/S
K151504ICS ImpulseGN OTOMETRICS
K143607I-Portal NOTC, VNG And VOGNEURO KINETICS, INC.

Global Unique Device Identification Database

00868096000300Nystagmograph
05713315005862Nystagmograph
05713315005282Nystagmograph
05713315005268Nystagmograph
05713315005244Nystagmograph
05713315004940Nystagmograph
05713315004148Nystagmograph
05713315002694Nystagmograph
05713315002656Nystagmograph
05713315002649Nystagmograph
05711117195989Nystagmograph
05711117180565Nystagmograph
05711117180558Nystagmograph
B516222210Nystagmograph
B516221350Nystagmograph

Maude Adverse Events

VIDEONYSTAGMOGRAPHYSECURE HEALTH INC. / S. A. INSTRUMENTATION DIFRA2019-11-12
ICS CHARTR 200 ENG/VNGNATUS MEDICAL DENMARK (GN OTOMETRICS)2019-09-05
ICS IMPULSE, 1085NATUS MEDICAL DENMARK APS (GN OTOMETRICS)2019-08-26
ICS CHARTR 200 ENG/VNGNATUS MEDICAL DENMARK (GN OTOMETRICS)2019-08-14
VNG HEARING TESTUNK2018-05-04
I-PORTAL NEURO-OTOLOGICAL TEST CENTERNEURO-KINETICS INC.2012-02-16
NEURO KINETICS BARANY CHAIR SYSTEMNEURO KINETICS, INC.2012-01-09
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