Product code GWN
- Device name
- Nystagmograph
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1460
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243709 | NeuroEars-Anna™ | Neuroears, Inc. | 2025-08-25 |
| K242198 | ICS Dizcovery (1091) | Natus Medical Denmark Aps | 2025-02-14 |
| K242726 | Synapsys VHIT | Inventis S.R.L. | 2025-01-03 |
| K223047 | NeuroSwift Pro | Neurobit Technologies Co., Ltd. | 2023-06-29 |
| K203082 | Insight Infrared Video Goggles | Vestibular First | 2020-11-12 |
| K200534 | VisualEyes | Interacoustics A/S | 2020-08-12 |
| K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph | Neurolign USA, LLC | 2019-11-29 |
| K181771 | RightEye Vision System | Righteye, LLC | 2018-09-28 |
| K182214 | DizzyDoctor System 1.0.0 | Dizzydoctor Systems, LLC | 2018-09-14 |
| 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 |
| K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | Neuro Kinetics, Inc. | 2017-11-22 |
| K163270 | ISEN-Goggles with Data Viewer | Isent Tech & Trading Company, Ltd. | 2017-09-25 |
| K163149 | VisualEyes | Interacoustics A/S | 2017-04-26 |
| K163558 | Synapsys Ulmer Video Nystagmograph | Synapsys SA | 2017-03-23 |
| K152727 | ISEN-Goggles | Isen Tech & Trading Company, Ltd. | 2016-04-26 |
| K152915 | EYE-SYNC | Syncthink, Inc. | 2016-01-29 |
| K152112 | VisualEyes | Interacoustics A/S | 2015-12-29 |
| K151504 | ICS Impulse | Gn Otometrics | 2015-11-16 |
| K143607 | I-Portal NOTC, VNG and VOG | Neuro Kinetics, Inc. | 2015-07-08 |
| K131681 | EYESEECAM VHIT | Interacoustics A/S | 2013-09-06 |
| K130201 | NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM | Ototronix, LLC | 2013-04-26 |
| K122550 | ICS IMPULSE | Gn Otometrics | 2013-02-01 |
| 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 |
| K072254 | VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM | Interacoustics A/S | 2008-02-05 |
| K070670 | EYETRACKER/IDEAS | S.A. Instrumentation Difra | 2007-09-18 |
| K070729 | BALANCEBACK MOBILE INTUITIVE VNG SYSTEM | Fall Prevention Technologies, LLC | 2007-03-30 |
| K062015 | CHRONOS VISION EYE TRACKING DEVICE (C-ETD) | Chronos Vision | 2006-10-31 |
| K061791 | FOCUS VNG/ENG TYPE 1068 | Gn Otometrics A/S | 2006-07-11 |
| K050098 | DDAT OMT | Ddat(Uk), Ltd. | 2005-05-23 |
| K042529 | BALANCEBACK VNG SYSTEM | Fall Prevention Technologies, LLC | 2004-10-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20763000467344 | NA | MEDTRONIC PS MEDICAL, INC. | 2024-03-01 |
| 00763000529369 | Becker | MEDTRONIC PS MEDICAL, INC. | 2024-02-26 |
| 00763000406080 | NA | MEDTRONIC PS MEDICAL, INC. | 2024-02-26 |
| 20763000467351 | NA | MEDTRONIC PS MEDICAL, INC. | 2024-02-26 |
| 20763000467382 | NA | MEDTRONIC PS MEDICAL, INC. | 2024-02-26 |
| 20763000467399 | NA | MEDTRONIC PS MEDICAL, INC. | 2024-02-26 |
| 00763000572952 | NA | MEDTRONIC PS MEDICAL, INC. | 2024-02-25 |
| 00763000529352 | NA | MEDTRONIC PS MEDICAL, INC. | 2024-02-25 |
| 00860002280745 | Vestibular First | Vestibular First, LLC | 2023-06-01 |
| 00860002280738 | Vestibular First | Vestibular First, LLC | 2021-11-11 |
| 00860002280707 | Vestibular First | Vestibular First, LLC | 2020-11-17 |
| 05711117223545 | Interacoustics | Interacoustics A/S | 2020-11-11 |
| 05711117223538 | Interacoustics | Interacoustics A/S | 2020-11-11 |
| B516220900 | Instrumentation Difra | Instrumentation Difra SA | 2020-06-18 |
| B516220920 | Instrumentation Difra | Instrumentation Difra SA | 2020-06-18 |
| 20763000343228 | N/A | MEDTRONIC PS MEDICAL, INC. | 2020-04-20 |
| B499V060 | ISEN-Goggles | ISEN Tech. & Trading Co.,Ltd. | 2017-09-01 |
| 03760184931503 | Kinetic Wi-Fi wireless VNG Ulmer system with Goggles Flex | SYNAPSYS | 2017-06-27 |
| 03760184931510 | Complete Monocular wireless Smart Cam system with Xpress mask | SYNAPSYS | 2017-06-27 |
| 03760184931527 | Complete Monocular wireless Smart Cam system with Goggles Flex | SYNAPSYS | 2017-06-27 |
| 08501830063873 | Micromedical Technologies | MICROMEDICAL TECHNOLOGIES, INC. | 2017-01-31 |
| 08501830061114 | Micromedical Technologies | MICROMEDICAL TECHNOLOGIES, INC. | 2016-09-24 |
| 08501830061107 | Micromedical Technologies | MICROMEDICAL TECHNOLOGIES, INC. | 2016-09-24 |
| 00673978246017 | NA | MEDTRONIC PS MEDICAL, INC. | 2015-07-21 |
| 00643169466142 | N/A | MEDTRONIC PS MEDICAL, INC. | 2015-07-15 |
| 20643169471522 | N/A | MEDTRONIC PS MEDICAL, INC. | 2015-07-15 |
| 20643169471515 | N/A | MEDTRONIC PS MEDICAL, INC. | 2015-07-15 |
| 20643169466122 | N/A | MEDTRONIC PS MEDICAL, INC. | 2015-07-15 |
| 00673978246031 | NA | MEDTRONIC PS MEDICAL, INC. | 2015-07-14 |
| 00673978228969 | NA | MEDTRONIC PS MEDICAL, INC. | 2015-06-18 |