The following data is part of a premarket notification filed by Neurolign Usa, Llc with the FDA for I-portal Neuro Otologic Test Center, I-portal Video Nystagmography System, I-portal Portable Assessment System - Nysragmograph.
| Device ID | K192186 |
| 510k Number | K192186 |
| Device Name: | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph |
| Classification | Nystagmograph |
| Applicant | Neurolign USA, LLC 128 Gamma Drive Pittsburgh, PA 15238 |
| Contact | Aura Kullmann |
| Correspondent | Aura Kullmann Neurolign USA, LLC 128 Gamma Drive Pittsburgh, PA 15238 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-12 |
| Decision Date | 2019-11-29 |