K130201 is an FDA 510(k) clearance for the NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM. This device is classified as a Nystagmograph (Class II - Special Controls, product code GWN).
Submitted by Ototronix, LLC (St. Paul, US). The FDA issued a Cleared decision on April 26, 2013, 88 days after receiving the submission on January 28, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1460.
| 510(k) Number | K130201 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2013 |
| Decision Date | April 26, 2013 |
| Days to Decision | 88 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 |