Device Classification Name |
audiometer
|
510(k) Number |
K881760 |
Device Name |
AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER |
Applicant |
AMERICAN ELECTROMEDICS CORP. |
13 SAGAMORE PARK RD. |
HUDSON,
NH
03051
|
|
Applicant Contact |
T. M GLEASON |
Correspondent |
AMERICAN ELECTROMEDICS CORP. |
13 SAGAMORE PARK RD. |
HUDSON,
NH
03051
|
|
Correspondent Contact |
T. M GLEASON |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 04/25/1988 |
Decision Date | 06/10/1988 |
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
|
|
|