K193033 is an FDA 510(k) clearance for the GSI Audera Pro. This device is classified as a Stimulator, Auditory, Evoked Response (Class II - Special Controls, product code GWJ).
Submitted by Grason Stadler (Eden Prairie, US). The FDA issued a Cleared decision on April 24, 2020, 176 days after receiving the submission on October 31, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1900.
| 510(k) Number | K193033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2019 |
| Decision Date | April 24, 2020 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWJ - Stimulator, Auditory, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1900 |