The following data is part of a premarket notification filed by Soundcure, Inc. with the FDA for Soundcure Serenade Tinnitus Treatment System.
| Device ID | K150065 |
| 510k Number | K150065 |
| Device Name: | SoundCure Serenade Tinnitus Treatment System |
| Classification | Masker, Tinnitus |
| Applicant | SoundCure, Inc. 560 S Winchester Blvd STE 500 San Jose, CA 95128 |
| Contact | William Perry |
| Correspondent | Diana Degregorio SoundCure, Inc. 560 S Winchester Blvd STE 500 San Jose, CA 95128 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-13 |
| Decision Date | 2015-04-13 |
| Summary: | summary |