GWN · Nystagmograph
Neurology · 21 CFR 882.1460 · Class 2
Overview
| Product Code | GWN |
|---|---|
| Device Name | Nystagmograph |
| Regulation | 21 CFR 882.1460 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 59)
Showing 20 most recent of 59 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243709 | NeuroEars-Anna | Neuroears, Inc. | Aug 25, 2025 | SESE |
| K242198 | ICS Dizcovery (1091) | Natus Medical Denmark Aps | Feb 14, 2025 | SESE |
| K242726 | Synapsys VHIT | Inventis S.R.L. | Jan 3, 2025 | SESE |
| K223047 | NeuroSwift Pro | Neurobit Technologies Co., Ltd. | Jun 29, 2023 | SESE |
| K203082 | Insight Infrared Video Goggles | Vestibular First | Nov 12, 2020 | SESE |
| K200534 | VisualEyes | Interacoustics A/S | Aug 12, 2020 | SESE |
| K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph | Neurolign USA, LLC | Nov 29, 2019 | SESE |
| K181771 | RightEye Vision System | Righteye, LLC | Sep 28, 2018 | SESE |
| K182214 | DizzyDoctor System 1.0.0 | Dizzydoctor Systems, LLC | Sep 14, 2018 | SESE |
| K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System | Neuro Kinetics, Inc. | Jul 24, 2018 | SESE |
| K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | Neuro Kinetics, Inc. | Nov 22, 2017 | SESE |
| K163270 | ISEN-Goggles with Data Viewer | Isent Tech & Trading Company, Ltd. | Sep 25, 2017 | SESE |
| K163149 | VisualEyes | Interacoustics A/S | Apr 26, 2017 | SESE |
| K163558 | Synapsys Ulmer Video Nystagmograph | Synapsys SA | Mar 23, 2017 | SESE |
| K152727 | ISEN-Goggles | Isen Tech & Trading Company, Ltd. | Apr 26, 2016 | SESE |
| K152915 | EYE-SYNC | Syncthink, Inc. | Jan 29, 2016 | SESE |
| K152112 | VisualEyes | Interacoustics A/S | Dec 29, 2015 | SESE |
| K151504 | ICS Impulse | Gn Otometrics | Nov 16, 2015 | SESE |
| K143607 | I-Portal NOTC, VNG and VOG | Neuro Kinetics, Inc. | Jul 8, 2015 | SESE |
| K131681 | EYESEECAM VHIT | Interacoustics A/S | Sep 6, 2013 | SESE |
Top Applicants
- Interacoustics A/S — 5 clearances
- Micromedical Technologies, Inc. — 3 clearances
- Neuro Kinetics, Inc. — 3 clearances
- Philadelphia Medical Specialties — 3 clearances
- Bio-Logic Systems Corp. — 2 clearances
