Device Classification Name |
hearing aid, bone conduction
|
510(k) Number |
K132189 |
Device Name |
OTOMAG BONE CONDUCATION HEARING SYSTEM |
Applicant |
SOPHONO, INC |
5744 CENTRAL AVENUE #100 |
BOULDER,
CO
80301
|
|
Applicant Contact |
KRISTA B TRAYNOR |
Correspondent |
SOPHONO, INC |
5744 CENTRAL AVENUE #100 |
BOULDER,
CO
80301
|
|
Correspondent Contact |
KRISTA B TRAYNOR |
Regulation Number | 874.3302
|
Classification Product Code |
|
Date Received | 07/15/2013 |
Decision Date | 11/22/2013 |
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
|
|
|