Device Classification Name |
Tester, Auditory Impedance
|
510(k) Number |
K953161 |
Device Name |
MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION |
Applicant |
MAICO HEARING INSTRUMENTS, INC. |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439 -2029
|
|
Applicant Contact |
MIKE CZURA |
Correspondent |
MAICO HEARING INSTRUMENTS, INC. |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439 -2029
|
|
Correspondent Contact |
MIKE CZURA |
Regulation Number | 874.1090
|
Classification Product Code |
|
Date Received | 07/07/1995 |
Decision Date | 07/24/1995 |
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
|
|
|