Device Classification Name |
masker, tinnitus
|
510(k) Number |
K151558 |
Device Name |
Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System |
Applicant |
NEUROTHERAPIES RESET GMBH. |
KARL-HEINZ-BECKHURTS-SRT.13 |
JUELICH,
DE
D-52428
|
|
Applicant Contact |
MICHAEL PELHAM MORRIS OLIVE |
Correspondent |
DEBORAH L. SHEFFIELD CONSULTING |
5672 FLAGLER ROAD |
NORDLAND,
WA
98358
|
|
Correspondent Contact |
DEBORAH SHEFFIELD |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 06/10/2015 |
Decision Date | 01/20/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|