Neurolign Dx SVNG - Nystagmograph
2020-07-01
Spryson America Inc
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2519945 | 2519945 | Spryson America Inc | 1 | N | 2026-01-01 | 201 N Braddock Ave Ste 301 Pittsburgh PA US 15208 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 325870 | 1722703063 | K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph | GWN | 2019-11-29 |
| 325870 | 1484783625 | K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System | GWN | 2018-07-24 |
| 325870 | 1043869007 | K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | GWN | 2017-11-22 |
| 325870 | 1070067348 | K143607 | I-Portal NOTC, VNG and VOG | GWN | 2015-07-08 |
| 325870 | 1990281953 | K083603 | I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL | GWN | 2009-08-06 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GWN | 5 | 2019-11-29 |
GUDID#
Neurolign Dx NOTC - Nystagmograph
2020-07-01
Neurolign Dx100 - Nystagmograph
2020-07-01