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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 K070670
Device Name EYETRACKER/IDEAS
Applicant
S.A. Instrumentation Difra
205 Co. Rd. 128a
Suite 200
Cheyenne,  WY  82007
Applicant Contact GUIDO PAGNACCO
Correspondent
S.A. Instrumentation Difra
205 Co. Rd. 128a
Suite 200
Cheyenne,  WY  82007
Correspondent Contact GUIDO PAGNACCO
Regulation Number882.1460
Classification Product Code
GWN  
Date Received03/12/2007
Decision Date 09/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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