Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K902846 |
Device Name |
PRIZM HEARING SYSTEM |
Applicant |
AUDIOSCIENCE, INC. |
5420 FELTL RD. |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
DEBRA S FRY |
Correspondent |
AUDIOSCIENCE, INC. |
5420 FELTL RD. |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
DEBRA S FRY |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 06/28/1990 |
Decision Date | 10/31/1990 |
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
|
|
|