Device Classification Name |
Masker, Tinnitus
|
510(k) Number |
K161562 |
Device Name |
Sound Options Tinnitus Treatment |
Applicant |
Sound Options Tinnitus Treatments Inc. |
3841 Ridgepoint Way |
Mississauga,
CA
L5N 7T7
|
|
Applicant Contact |
Michael Chrostowski |
Correspondent |
AxSource Consulting Inc. |
336 Bronte Street South, Suite 224-225 |
Milton,
CA
l9t 7w6
|
|
Correspondent Contact |
Navneet Sekhon |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 06/06/2016 |
Decision Date | 09/28/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|