Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K932426 |
Device Name |
BELTONE OPERA/OPERA MHP/OPERA MAX |
Applicant |
BELTONE ELECTRONICS CORP. |
4201 WEST VICTORIA ST. |
CHICAGO,
IL
60646
|
|
Applicant Contact |
ROBERT KRATOCHVIL |
Correspondent |
BELTONE ELECTRONICS CORP. |
4201 WEST VICTORIA ST. |
CHICAGO,
IL
60646
|
|
Correspondent Contact |
ROBERT KRATOCHVIL |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 05/19/1993 |
Decision Date | 07/14/1993 |
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
|
|
|