Device Classification Name |
Audiometer
|
510(k) Number |
K962275 |
Device Name |
MAICO MA25 SERIES II WITH SPEECH |
Applicant |
BERNAFON-MAICO, INC. |
9675 WEST 76TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
SCOTT SAVRE |
Correspondent |
BERNAFON-MAICO, INC. |
9675 WEST 76TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
SCOTT SAVRE |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 06/13/1996 |
Decision Date | 09/05/1996 |
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
|
|
|