Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K971031 |
Device Name |
AUDALLION III HEARING SYSTEM |
Applicant |
GN DANAVOX, INC. |
5600 ROWLAND RD., SUITE 250 |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
WAYNE E MORRIS |
Correspondent |
GN DANAVOX, INC. |
5600 ROWLAND RD., SUITE 250 |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
WAYNE E MORRIS |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 03/21/1997 |
Decision Date | 06/17/1997 |
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
|
|
|