The following data is part of a premarket notification filed by Diagnostic Group, Dba Grason-stadler with the FDA for Gsi Tympstar Pro Middle Ear Analyzer.
| Device ID | K151509 |
| 510k Number | K151509 |
| Device Name: | GSI TympStar Pro Middle Ear Analyzer |
| Classification | Tester, Auditory Impedance |
| Applicant | Diagnostic Group, Dba Grason-Stadler 7625 Golden Triangle Drive, Suite F Eden Prairie, MN 55344 |
| Contact | Ron Rolfsen |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-06-04 |
| Decision Date | 2015-06-25 |