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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nystagmograph
510(k) Number K972631
Device Name ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER
Applicant
ICS MEDICAL CORP.
2227 HAMMOND DR.
SCHAUMBURG,  IL  60173 -3860
Applicant Contact DELMAR F BLOEM
Correspondent
ICS MEDICAL CORP.
2227 HAMMOND DR.
SCHAUMBURG,  IL  60173 -3860
Correspondent Contact DELMAR F BLOEM
Regulation Number882.1460
Classification Product Code
GWN  
Date Received07/14/1997
Decision Date 09/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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