GN Otometrics A/S
1085 Vision Denied Solution Kit (200 Sets) 8-62-50700
3manufacturers in China registered for this device type
17catalogue numbers in this listing
1510(k) clearance
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 | Natus Medical Denmark ApS, Denmark |
|---|---|
| FDA product code | GWN |
| Device type | Nystagmograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1460 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K122550 |
| Record published | 2016-09-26 |
| Record revised | 2026-04-10 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2019-04-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Disposable Electrode 24″ Wired Qty 10 | In distribution | |
| 1047, HEADSTRAP COMP | In distribution | |
| Strap assembly | In distribution | |
| 1085 Vision Denied Solution Kit (50 sets) | In distribution | |
| Monocular Positional | In distribution | |
| Lateral Head Impulse | In distribution | |
| 1085, VOLUME VISION DENIED BOX | In distribution | |
| ICS Impulse | In distribution | |
| ICS Impulse | In distribution | |
| Disposable Electrodes Snap Qty 20 | In distribution | |
| LARP/RALP Head Impulse | In distribution | |
| Torsional Module | In distribution | |
| Monocular Oculomotor Limited | In distribution | |
| Goggle Upgrade for Lateral/LARP/RALP | In distribution | |
| ICS Monocular VNG Video/oculd/Posit kit (US Version) | In distribution | |
| VH-40 Video Goggles | In distribution | |
| 1085, GOGGLE HOME KIT | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Interacoustics | Interacoustics A/S | 15 |
| 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 |
|---|---|
| K242198 | 2025-02-14 |
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.