GWN — Nystagmograph Class II
FDA product code GWN covers "Nystagmograph", a Class II medical device regulated under 21 CFR 882.1460. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GWN
- Device Class
- Class II
- Regulation Number
- 882.1460
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243709 | neuroears | NeuroEars-Anna | August 25, 2025 |
| K242198 | natus medical denmark aps | ICS Dizcovery (1091) | February 14, 2025 |
| K242726 | inventis | Synapsys VHIT | January 3, 2025 |
| K223047 | neurobit technologies co | NeuroSwift Pro | June 29, 2023 |
| K203082 | vestibular first | Insight Infrared Video Goggles | November 12, 2020 |
| K200534 | interacoustics | VisualEyes | August 12, 2020 |
| K192186 | neurolign usa | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Por | November 29, 2019 |
| K181771 | righteye | RightEye Vision System | September 28, 2018 |
| K182214 | dizzydoctor systems | DizzyDoctor System 1.0.0 | September 14, 2018 |
| K181025 | neuro kinetics | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Por | July 24, 2018 |
| K171884 | neuro kinetics | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | November 22, 2017 |
| K163270 | isent tech and trading company | ISEN-Goggles with Data Viewer | September 25, 2017 |
| K163149 | interacoustics | VisualEyes | April 26, 2017 |
| K163558 | synapsys | Synapsys Ulmer Video Nystagmograph | March 23, 2017 |
| K152727 | isen tech and trading company | ISEN-Goggles | April 26, 2016 |
| K152915 | syncthink | EYE-SYNC | January 29, 2016 |
| K152112 | interacoustics | VisualEyes | December 29, 2015 |
| K151504 | gn otometrics | ICS Impulse | November 16, 2015 |
| K143607 | neuro kinetics | I-Portal NOTC, VNG and VOG | July 8, 2015 |
| K131681 | interacoustics | EYESEECAM VHIT | September 6, 2013 |