K200534 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 August 12, 2020, 163 days after receiving the submission on March 2, 2020.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 882.1460.
| 510(k) Number | K200534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2020 |
| Decision Date | August 12, 2020 |
| Days to Decision | 163 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 |