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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 K013060
Device Name ICS MEDICAL MODEL VG-30 VIDEO GOGGLES
Applicant
ICS MEDICAL
125 COMMERCE DR.
SCHAUMBURG,  IL  60173 -5329
Applicant Contact ROBERT M SIMENSON
Correspondent
ICS MEDICAL
125 COMMERCE DR.
SCHAUMBURG,  IL  60173 -5329
Correspondent Contact ROBERT M SIMENSON
Regulation Number882.1460
Classification Product Code
GWN  
Date Received09/11/2001
Decision Date 12/10/2001
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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