The following data is part of a premarket notification filed by Grason Stadler with the FDA for Gsi Audera Pro.
| Device ID | K193033 |
| 510k Number | K193033 |
| Device Name: | GSI Audera Pro |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | Grason Stadler 10395 West 70th Street Eden Prairie, MN 55344 |
| Contact | Brent Nissly |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct. Naples, FL 34114 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-31 |
| Decision Date | 2020-04-24 |