Device Classification Name |
Hearing Aid, Bone Conduction
|
510(k) Number |
K100649 |
Device Name |
SOUNDBITE HEARING SYSTEM BY SONITUS |
Applicant |
SONITUS MEDICAL INC |
25 HARTFORD AVE |
SAN CARLOS,
CA
94070
|
|
Applicant Contact |
ROBERT J CHIN |
Correspondent |
SONITUS MEDICAL INC |
25 HARTFORD AVE |
SAN CARLOS,
CA
94070
|
|
Correspondent Contact |
ROBERT J CHIN |
Regulation Number | 874.3302
|
Classification Product Code |
|
Date Received | 03/08/2010 |
Decision Date | 01/14/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00977314
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|