Device Classification Name |
audiometer
|
510(k) Number |
K031986 |
Device Name |
ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS |
Applicant |
ICS MEDICAL |
125 COMMERCE DR. |
SCHAUMBURG,
IL
60173 -5329
|
|
Applicant Contact |
DELMAR F BLOEM |
Correspondent |
ICS MEDICAL |
125 COMMERCE DR. |
SCHAUMBURG,
IL
60173 -5329
|
|
Correspondent Contact |
DELMAR F BLOEM |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 06/27/2003 |
Decision Date | 07/24/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|