Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K940177 |
Device Name |
OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP) |
Applicant |
BELTONE ELECTRONICS CORP. |
4201 WEST VICTORIA ST. |
CHICAGO,
IL
60646
|
|
Applicant Contact |
ROBERT A KRATOCHVILL |
Correspondent |
BELTONE ELECTRONICS CORP. |
4201 WEST VICTORIA ST. |
CHICAGO,
IL
60646
|
|
Correspondent Contact |
ROBERT A KRATOCHVILL |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 01/11/1994 |
Decision Date | 04/01/1994 |
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
|
|
|