Device Classification Name |
Audiometer
|
510(k) Number |
K822745 |
Device Name |
THE SCREENING TYMPANOMETER |
Applicant |
AMERICAN ELECTROMEDICS CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
AMERICAN ELECTROMEDICS CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 09/10/1982 |
Decision Date | 09/30/1982 |
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
|
|
|