Device Classification Name |
Hearing Aid, Bone Conduction
|
510(k) Number |
K121793 |
Device Name |
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON |
Applicant |
AUDIFON-USA INC. |
403 CHAIRMAN CT., STE. 1 |
DEBARY,
FL
32713
|
|
Applicant Contact |
JANE E PERRONE |
Correspondent |
AUDIFON-USA INC. |
403 CHAIRMAN CT., STE. 1 |
DEBARY,
FL
32713
|
|
Correspondent Contact |
JANE E PERRONE |
Regulation Number | 874.3302
|
Classification Product Code |
|
Date Received | 06/19/2012 |
Decision Date | 11/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|