Device Classification Name |
audiometer
|
510(k) Number |
K972221 |
Device Name |
K 15 AUDIOMETER |
Applicant |
AMERICAN ELECTROMEDICS CORP. |
13 COLUMBUS DR. |
SUITE 18 |
AMHERST,
NH
03031
|
|
Applicant Contact |
MICHAEL T PIENIAZEK |
Correspondent |
AMERICAN ELECTROMEDICS CORP. |
13 COLUMBUS DR. |
SUITE 18 |
AMHERST,
NH
03031
|
|
Correspondent Contact |
MICHAEL T PIENIAZEK |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 06/13/1997 |
Decision Date | 09/08/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|