Device Classification Name |
masker, tinnitus
|
510(k) Number |
K093715 |
Device Name |
EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE |
Applicant |
MAGNATONE HEARING AID CORP. DBA PERSONA MEDICAL |
170 N. CYPRESS WAY |
CASSELBERRY,
FL
32707
|
|
Applicant Contact |
DON CAMPBELL |
Correspondent |
MAGNATONE HEARING AID CORP. DBA PERSONA MEDICAL |
170 N. CYPRESS WAY |
CASSELBERRY,
FL
32707
|
|
Correspondent Contact |
DON CAMPBELL |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 12/01/2009 |
Decision Date | 12/22/2010 |
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
|
|
|