Device Classification Name |
Audiometer
|
510(k) Number |
K011181 |
Device Name |
ICS MEDICAL CHARTR OAE WITH TYMP |
Applicant |
ICS MEDICAL CORP. |
125 COMMERCE DR. |
SCHAUMBURG,
IL
60173 -5329
|
|
Applicant Contact |
DELMAR F BLOEM |
Correspondent |
ICS MEDICAL CORP. |
125 COMMERCE DR. |
SCHAUMBURG,
IL
60173 -5329
|
|
Correspondent Contact |
DELMAR F BLOEM |
Regulation Number | 874.1050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/18/2001 |
Decision Date | 06/25/2001 |
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
|
|
|