Device Classification Name |
Audiometer
|
510(k) Number |
K802350 |
Device Name |
ATTENU-CHEK |
Applicant |
HEAR CO., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
HEAR CO., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 09/25/1980 |
Decision Date | 10/23/1980 |
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
|
|
|