510(k) K982103
- Device
- ULMER (VNG) VIDEO NYSTAGMOGRAPH
- Applicant
- SYNAPSYS, INC.
- 510(k) number
- K982103
- Product code
- GWN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-09-11
- Date received
- 1998-06-15
- Regulation
- 882.1460
- Classification name
- Nystagmograph
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- VERA BUFFALOE
- Address
- 1400 Main St. Louisville CO US 80027 80027
FDA Registration Numbers#
- 3014133165
- 3005581270
- 3017632068
- 3009391819
- 3011310592
- 3011522961
- 9710051
- 3034880867
- 3008699634
- 3007532396
- 3005216736
- 2519945
- 9710334
- 3016159411
- 9612197
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GWN #
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases