FDA Product Code
FDA Product Code GWN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1460
510(k) Clearances — 60 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260566 | SMARTVERTIGO Vestibular Assessment System | VertigoDx, Inc. | 2026-07-30 | Traditional | PDF ↗ |
| K243709 | NeuroEars-Anna | Neuroears, Inc. | 2025-08-25 | Traditional | PDF ↗ |
| K242198 | ICS Dizcovery (1091) | Natus Medical Denmark Aps | 2025-02-14 | Traditional | PDF ↗ |
| K242726 | Synapsys VHIT | Inventis S.R.L. | 2025-01-03 | Traditional | PDF ↗ |
| K223047 | NeuroSwift Pro | Neurobit Technologies Co., Ltd. | 2023-06-29 | Traditional | PDF ↗ |
| K203082 | Insight Infrared Video Goggles | Vestibular First | 2020-11-12 | Traditional | PDF ↗ |
| K200534 | VisualEyes | Interacoustics A/S | 2020-08-12 | Traditional | PDF ↗ |
| K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph | Neurolign USA, LLC | 2019-11-29 | Traditional | PDF ↗ |
| K181771 | RightEye Vision System | Righteye, LLC | 2018-09-28 | Traditional | PDF ↗ |
| K182214 | DizzyDoctor System 1.0.0 | Dizzydoctor Systems, LLC | 2018-09-14 | Traditional | PDF ↗ |
| K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System | Neuro Kinetics, Inc. | 2018-07-24 | Special | PDF ↗ |
| K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | Neuro Kinetics, Inc. | 2017-11-22 | Traditional | PDF ↗ |
| K163270 | ISEN-Goggles with Data Viewer | Isent Tech & Trading Company, Ltd. | 2017-09-25 | Traditional | PDF ↗ |
| K163149 | VisualEyes | Interacoustics A/S | 2017-04-26 | Traditional | PDF ↗ |
| K163558 | Synapsys Ulmer Video Nystagmograph | Synapsys SA | 2017-03-23 | Special | PDF ↗ |
| K152727 | ISEN-Goggles | Isen Tech & Trading Company, Ltd. | 2016-04-26 | Traditional | PDF ↗ |
| K152915 | EYE-SYNC | Syncthink, Inc. | 2016-01-29 | Traditional | PDF ↗ |
| K152112 | VisualEyes | Interacoustics A/S | 2015-12-29 | Traditional | PDF ↗ |
| K151504 | ICS Impulse | Gn Otometrics | 2015-11-16 | Traditional | PDF ↗ |
| K143607 | I-Portal NOTC, VNG and VOG | Neuro Kinetics, Inc. | 2015-07-08 | Traditional | PDF ↗ |
| K131681 | EYESEECAM VHIT | Interacoustics A/S | 2013-09-06 | Traditional | PDF ↗ |
| K130201 | NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM | Ototronix, LLC | 2013-04-26 | Traditional | PDF ↗ |
| K122550 | ICS IMPULSE | Gn Otometrics | 2013-02-01 | Traditional | PDF ↗ |
| K083603 | I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL | Neuro Kinetics | 2009-08-06 | Traditional | PDF ↗ |
| K072254 | VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM | Interacoustics A/S | 2008-02-05 | Traditional | PDF ↗ |
| K070670 | EYETRACKER/IDEAS | S.A. Instrumentation Difra | 2007-09-18 | Traditional | PDF ↗ |
| K070729 | BALANCEBACK MOBILE INTUITIVE VNG SYSTEM | Fall Prevention Technologies, LLC | 2007-03-30 | Traditional | PDF ↗ |
| K062015 | CHRONOS VISION EYE TRACKING DEVICE (C-ETD) | Chronos Vision | 2006-10-31 | Traditional | PDF ↗ |
| K061791 | FOCUS VNG/ENG TYPE 1068 | Gn Otometrics A/S | 2006-07-11 | Traditional | PDF ↗ |
| K050098 | DDAT OMT | Ddat(Uk), Ltd. | 2005-05-23 | Traditional | PDF ↗ |
| K042529 | BALANCEBACK VNG SYSTEM | Fall Prevention Technologies, LLC | 2004-10-06 | Traditional | PDF ↗ |
| K013060 | ICS MEDICAL MODEL VG-30 VIDEO GOGGLES | Ics Medical | 2001-12-10 | Traditional | PDF ↗ |
| K010059 | ENGPLUS | Western Systems Research, Inc. | 2001-02-27 | Traditional | PDF ↗ |
| K003644 | EYETECT TREMOR MONITOR UNIT (TMU) | Eyetect, LLC | 2001-02-01 | Traditional | PDF ↗ |
| K992473 | EXPRESSEYE | Optomotor Laboratories | 1999-08-12 | Traditional | PDF ↗ |
| K991642 | EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX | Bertec Corp. | 1999-08-03 | Abbreviated | PDF ↗ |
| K991497 | ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM | Ics Medical Corp. | 1999-07-28 | Traditional | PDF ↗ |
| K982103 | ULMER (VNG) VIDEO NYSTAGMOGRAPH | Synapsys, Inc. | 1998-09-11 | Traditional | PDF ↗ |
| K972631 | ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER | Ics Medical Corp. | 1997-09-22 | Traditional | PDF ↗ |
| K972243 | 2D VOG - VIDEO-OCULOGRAPHY | Sensomotoric Instruments, GmbH | 1997-09-10 | Traditional | PDF ↗ |
| K964325 | VISUALEYES: VIDEO EYE MONITOR | Micromedical Technologies, Inc. | 1997-07-15 | Traditional | PDF ↗ |
| K964646 | VIDEO EYE TRAKKER | Micromedical Technologies, Inc. | 1997-07-15 | Traditional | PDF ↗ |
| K941928 | VARIOUS ELECTRODES | Bio-Logic Systems Corp. | 1995-02-03 | Traditional | PDF ↗ |
| K926312 | INFRARED EYE MOVEMENT MONITOR | Microguide, Inc. | 1994-12-15 | Traditional | PDF ↗ |
| K925111 | HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM | Eye Dynamics, Inc. | 1994-03-23 | Traditional | PDF ↗ |
| K904385 | JANUS ATAC ENG ANALYSIS SYSTEM | Life-Tech Intl., Inc. | 1992-06-10 | Traditional | PDF ↗ |
| K884294 | NICOLET NYSTAR PLUS SYSTEM | Nicolet Instrument Corp. | 1988-11-23 | Traditional | PDF ↗ |
| K871466 | VESTIBULAR AUTOROTATION TEST | Western Systems Research, Inc. | 1987-07-24 | Traditional | PDF ↗ |
| K863424 | COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE | Micromedical Technologies, Inc. | 1987-03-23 | Traditional | PDF ↗ |
| K860457 | ELECTROCARDIOGRAPH CONTINUOUS MONITOR | Oxford Medilog, Inc. | 1986-04-30 | Traditional | PDF ↗ |
| K851190 | NYSTAGMOGRAPH EOG/ENG ANALYSES | Nicolet Biomedical Instruments | 1985-11-27 | Traditional | PDF ↗ |
| K850180 | ELECTRONYSTAGMOGRAPH (ENG RECORDER) | Bio-Logic Systems Corp. | 1985-07-22 | Traditional | PDF ↗ |
| K842886 | TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL | Teca, Inc. | 1984-12-12 | Traditional | PDF ↗ |
| K843004 | SERVO MED NYSTAGMOGRAPH NG-1 | Servo Med, Inc. | 1984-10-30 | Traditional | PDF ↗ |
| K834148 | PHILLY BOLTS | Philadelphia Medical Specialties | 1984-02-10 | Traditional | PDF ↗ |
| K822268 | NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH | Kelleher Corp. | 1983-01-28 | Traditional | PDF ↗ |
| K823459 | PHILLY BOLT ADULT PROCEDURE KIT | Philadelphia Medical Specialties | 1982-12-22 | Traditional | PDF ↗ |
| K822266 | NAGASHIMA KN-52 SACCADE & PURSUIT STIM | Kelleher Corp. | 1982-08-16 | Traditional | PDF ↗ |
| K820151 | PHILLY INFANT BOLT | Philadelphia Medical Specialties | 1982-01-28 | Traditional | PDF ↗ |
| K812180 | LIFE-TECH #5102 VISULAB | Life-Tech Instruments, Inc. | 1981-08-21 | Traditional | PDF ↗ |
Product code GWN · Class II · Neurology. Data: openFDA.