Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K963745 |
Device Name |
MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) |
Applicant |
HEARING INNOVATIONS, INC. |
3567 EAST SUNRISE DR. |
SUITE 101 |
TUCSON,
AZ
85718
|
|
Applicant Contact |
ROBERT S GREEN |
Correspondent |
HEARING INNOVATIONS, INC. |
3567 EAST SUNRISE DR. |
SUITE 101 |
TUCSON,
AZ
85718
|
|
Correspondent Contact |
ROBERT S GREEN |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 09/17/1996 |
Decision Date | 11/26/1996 |
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
|
|
|