K163149 is an FDA 510(k) clearance for the VisualEyes. This device is classified as a Nystagmograph (Class II - Special Controls, product code GWN).
Submitted by Interacoustics A/S (Middelfart, DK). The FDA issued a Cleared decision on April 26, 2017, 168 days after receiving the submission on November 9, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1460.
| 510(k) Number | K163149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2016 |
| Decision Date | April 26, 2017 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWN - Nystagmograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1460 |