FDA 510(k) Applications for Medical Device Product Code "GWN"
(Nystagmograph)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K991642 | BERTEC CORP. | EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX | 08/03/1999 |
| K062015 | CHRONOS VISION | CHRONOS VISION EYE TRACKING DEVICE (C-ETD) | 10/31/2006 |
| K050098 | DDAT(UK) LTD | DDAT OMT | 05/23/2005 |
| K182214 | DizzyDoctor Systems, LLC | DizzyDoctor System 1.0.0 | 09/14/2018 |
| K003644 | EYETECT, L.L.C. | EYETECT TREMOR MONITOR UNIT (TMU) | 02/01/2001 |
| K070729 | FALL PREVENTION TECHNOLOGIES, LLC | BALANCEBACK MOBILE INTUITIVE VNG SYSTEM | 03/30/2007 |
| K042529 | FALL PREVENTION TECHNOLOGIES, LLC | BALANCEBACK VNG SYSTEM | 10/06/2004 |
| K122550 | GN OTOMETRICS | ICS IMPULSE | 02/01/2013 |
| K151504 | GN OTOMETRICS | ICS Impulse | 11/16/2015 |
| K061791 | GN OTOMETRICS A/S | FOCUS VNG/ENG TYPE 1068 | 07/11/2006 |
| K013060 | ICS MEDICAL | ICS MEDICAL MODEL VG-30 VIDEO GOGGLES | 12/10/2001 |
| K991497 | ICS MEDICAL CORP. | ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM | 07/28/1999 |
| K972631 | ICS MEDICAL CORP. | ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER | 09/22/1997 |
| K131681 | INTERACOUSTICS A/S | EYESEECAM VHIT | 09/06/2013 |
| K152112 | INTERACOUSTICS A/S | VisualEyes | 12/29/2015 |
| K163149 | Interacoustics A/S | VisualEyes | 04/26/2017 |
| K200534 | Interacoustics A/S | VisualEyes | 08/12/2020 |
| K072254 | INTERACOUSTICS A/S | VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM | 02/05/2008 |
| K152727 | ISEN TECH & TRADING COMPANY, LTD. | ISEN-Goggles | 04/26/2016 |
| K163270 | ISENT TECH & TRADING COMPANY,LTD. | ISEN-Goggles with Data Viewer | 09/25/2017 |
| K964646 | MICROMEDICAL TECHNOLOGIES, INC. | VIDEO EYE TRAKKER | 07/15/1997 |
| K964325 | MICROMEDICAL TECHNOLOGIES, INC. | VISUALEYES: VIDEO EYE MONITOR | 07/15/1997 |
| K083603 | NEURO KINETICS | I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL | 08/06/2009 |
| K171884 | Neuro Kinetics, Inc | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | 11/22/2017 |
| K181025 | Neuro Kinetics, Inc. | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System | 07/24/2018 |
| K143607 | NEURO KINETICS, INC. | I-Portal NOTC, VNG and VOG | 07/08/2015 |
| K223047 | Neurobit Technologies Co., Ltd. | NeuroSwift Pro | 06/29/2023 |
| K192186 | Neurolign USA, LLC | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph | 11/29/2019 |
| K992473 | OPTOMOTOR LABORATORIES | EXPRESSEYE | 08/12/1999 |
| K130201 | OTOTRONIX, LLC | NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM | 04/26/2013 |
| K181771 | RightEye, LLC | RightEye Vision System | 09/28/2018 |
| K070670 | S.A. INSTRUMENTATION DIFRA | EYETRACKER/IDEAS | 09/18/2007 |
| K972243 | SENSOMOTORIC INSTRUMENTS, GMBH | 2D VOG - VIDEO-OCULOGRAPHY | 09/10/1997 |
| K163558 | Synapsys SA | Synapsys Ulmer Video Nystagmograph | 03/23/2017 |
| K982103 | SYNAPSYS, INC. | ULMER (VNG) VIDEO NYSTAGMOGRAPH | 09/11/1998 |
| K152915 | SyncThink, Inc. | EYE-SYNC | 01/29/2016 |
| K203082 | Vestibular First | Insight Infrared Video Goggles | 11/12/2020 |
| K010059 | WESTERN SYSTEMS RESEARCH, INC. | ENGPLUS | 02/27/2001 |
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