The following data is part of a premarket notification filed by Neurotherapies Reset Gmbh. with the FDA for Desyncra For Tinnitus Therapy System, Desyncra For Tinnitus Pro System.
| Device ID | K151558 |
| 510k Number | K151558 |
| Device Name: | Desyncra For Tinnitus Therapy System, Desyncra For Tinnitus Pro System |
| Classification | Masker, Tinnitus |
| Applicant | NEUROTHERAPIES RESET GMBH. KARL-HEINZ-BECKHURTS-SRT.13 Juelich, DE D-52428 |
| Contact | Michael Pelham Morris Olive |
| Correspondent | Deborah Sheffield DEBORAH L. SHEFFIELD CONSULTING 5672 FLAGLER ROAD Nordland, WA 98358 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-10 |
| Decision Date | 2016-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDYGTI1004EU01 | K151558 | 000 |
| EDYGTI1003EU01 | K151558 | 000 |
| EDYGTI1002EU01 | K151558 | 000 |
| EDYGTI1001EU01 | K151558 | 000 |