K192186 is an FDA 510(k) clearance for the I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph. This device is classified as a Nystagmograph (Class II - Special Controls, product code GWN).
Submitted by Neurolign USA, LLC (Pittsburgh, US). The FDA issued a Cleared decision on November 29, 2019, 109 days after receiving the submission on August 12, 2019.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 882.1460.
| 510(k) Number | K192186 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2019 |
| Decision Date | November 29, 2019 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | GWN - Nystagmograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1460 |