The following data is part of a premarket notification filed by Turtle Beach Corporation with the FDA for Hypersound Tinnitus Module.
| Device ID | K161331 |
| 510k Number | K161331 |
| Device Name: | HyperSound Tinnitus Module |
| Classification | Masker, Tinnitus |
| Applicant | TURTLE BEACH CORPORATION 12220 SCRIPPS SUMMIT DRIVE, SUITE 100 San Diego, CA 92131 |
| Contact | James A. Barnes |
| Correspondent | James A. Barnes TURTLE BEACH CORPORATION 12220 SCRIPPS SUMMIT DRIVE, SUITE 100 San Diego, CA 92131 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-12 |
| Decision Date | 2016-08-23 |
| Summary: | summary |