The following data is part of a premarket notification filed by Hansaton Akustik Gmbh with the FDA for Wave 2g, Soul.
| Device ID | K130937 |
| 510k Number | K130937 |
| Device Name: | WAVE 2G, SOUL |
| Classification | Masker, Tinnitus |
| Applicant | HANSATON AKUSTIK GMBH BEIM STROHHAUSE 17 Hamburg, DE 20097 |
| Contact | Nick Burmester |
| Correspondent | Nick Burmester HANSATON AKUSTIK GMBH BEIM STROHHAUSE 17 Hamburg, DE 20097 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-04 |
| Decision Date | 2014-01-03 |
| Summary: | summary |