ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS


information about

Device Classification Name

stimulator, auditory, evoked response

510(k) Number K002985
Device Name ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
Original Applicant
ICS MEDICAL CORP.
125 commerce dr.
schaumburg, 
IL 
60173 -5329

Original Contact delmar f bloem
Regulation Number 882.1900
Classification Product Code
GWJ  
Subsequent Product Code
EWO  
Date Received 09/25/2000
Decision Date 12/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Ear Nose & Throat

Type Traditional
Reviewed by Third Party No

Combination Product

No