The following data is part of a premarket notification filed by Sound Options Tinnitus Treatments Inc. with the FDA for Sound Options Tinnitus Treatment.
| Device ID | K161562 |
| 510k Number | K161562 |
| Device Name: | Sound Options Tinnitus Treatment |
| Classification | Masker, Tinnitus |
| Applicant | Sound Options Tinnitus Treatments Inc. 3841 Ridgepoint Way Mississauga, CA L5n 7t7 |
| Contact | Michael Chrostowski |
| Correspondent | Navneet Sekhon AxSource Consulting Inc. 336 Bronte Street South, Suite 224-225 Milton, CA L9t 7w6 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-06 |
| Decision Date | 2016-09-28 |
| Summary: | summary |