1091, ICS Dizcovery System
Catalogue number 8-04-16400, listed by Natus Medical Denmark ApS, Denmark, under Nystagmograph. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
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 |
| Record published | 2025-02-21 |
| Record revised | 2025-10-30 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8-04-16400 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GN Otometrics A/S | Natus Medical Denmark ApS | 17 |
| 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 |
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.