Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K882004 |
Device Name |
AUDINA |
Applicant |
AMERICAN AUDIO SERVICES, INC. |
P.O. BOX 580 |
AMBRIDGE,
PA
15003
|
|
Applicant Contact |
SCHNEIDER, M.S. |
Correspondent |
AMERICAN AUDIO SERVICES, INC. |
P.O. BOX 580 |
AMBRIDGE,
PA
15003
|
|
Correspondent Contact |
SCHNEIDER, M.S. |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 05/13/1988 |
Decision Date | 06/01/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|