Interacoustics
15 catalogue numbers from VisualEyes EyeSeeCam vHIT, listed by Interacoustics A/S, Denmark, under Nystagmograph. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
15catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Isen Tech.&Trading Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| E-Business International Inc. | Shenzhen | Guangdong | Exporter | 2 |
| Huizhou Maxway Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Interacoustics A/S, Denmark |
|---|---|
| FDA product code | GWN |
| Device type | Nystagmograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1460 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K163149 |
| Record published | 2025-08-14 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VisualEyes EyeSeeCam vHIT | In distribution | |
| VisualEyes 515 | In distribution | |
| VisualEyes 525 | In distribution | |
| VisualEyes 525 | In distribution | |
| Orion Comprehensive Basic | In distribution | |
| 2D-VOGfw | In distribution | |
| Vorteq | In distribution | |
| VisualEyes 515 | In distribution | |
| VisualEyes 505 | In distribution | |
| VisualEyes 505 | In distribution | |
| VisualEyes 505 | In distribution | |
| EyeSeeCam | In distribution | |
| VisualEyes 525 | In distribution | |
| Orion Autotraverse Basic | In distribution | |
| VisualEyes EyeSeeCam vHIT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GN Otometrics A/S | Natus Medical Denmark ApS | 17 |
| VNG | Inventis SRL | 9 |
| Instrumentation Difra SA | Instrumentation Difra SA | 8 |
| Nystagmograph | Medtronic PS Medical | 7 |
| Instrumentation Difra | Instrumentation Difra SA | 7 |
| Otometrics | Natus Medical Denmark ApS | 5 |
| Vestibular First | Vestibular First | 4 |
| Micromedical Technologies | Micromedical Technologies, Inc. | 3 |
| Complete Monocular wireless Smart Cam system with Xpress mask | Synapsys SA | 2 |
| Synapsys Vhit | Inventis SRL | 2 |
| EYE-Sync | Neurosync, Inc. | 2 |
| I-Portal Super VNG | N K I | 2 |
Showing 12 of 37. All products under Nystagmograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200534 | 2020-08-12 |
| K163149 | 2017-04-26 |
| K152112 | 2015-12-29 |
| K131681 | 2013-09-06 |
| K072254 | 2008-02-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.