The following data is part of a premarket notification filed by Gn Hearing A/s with the FDA for Tinnitus Sound Generator Module.
| Device ID | K181586 |
| 510k Number | K181586 |
| Device Name: | Tinnitus Sound Generator Module |
| Classification | Masker, Tinnitus |
| Applicant | GN Hearing A/S Lautrupbjerg 7 Ballerup, DK 2750 |
| Contact | Lars Hagander |
| Correspondent | Lars Hagander GN Hearing A/S Lautrupbjerg 7 Ballerup, DK 2750 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-15 |
| Decision Date | 2018-07-13 |
| Summary: | summary |