K203082 is an FDA 510(k) clearance for the Insight Infrared Video Goggles. This device is classified as a Nystagmograph (Class II - Special Controls, product code GWN).
Submitted by Vestibular First (Broomall, US). The FDA issued a Cleared decision on November 12, 2020, 30 days after receiving the submission on October 13, 2020.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 882.1460.
| 510(k) Number | K203082 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 2020 |
| Decision Date | November 12, 2020 |
| Days to Decision | 30 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 |