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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 -1831
Applicant Contact GUIDO PAGNACCO
Correspondent
S.A. INSTRUMENTATION DIFRA
205 CO. RD. 128A
SUITE 200
CHEYENNE,  WY  82007 -1831
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
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