Device Classification Name |
Hearing Aid, Bone Conduction
|
510(k) Number |
K951678 |
Device Name |
HI SONIC 2000 DIGITAL HEARING INSTRUMENT |
Applicant |
HEARING INNOVATIONS, INC. |
COLUMBIA SQUARE |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
HEARING INNOVATIONS, INC. |
COLUMBIA SQUARE |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 874.3302
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/11/1995 |
Decision Date | 06/07/1995 |
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
|
|
|