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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 K925111
FOIA Releasable 510(k) K925111
Device Name HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM
Applicant
Eye Dynamics, Inc.
2291 205th St., Suite 203
Torrance,  CA  90501
Applicant Contact RONALD A WALDORF
Correspondent
Eye Dynamics, Inc.
2291 205th St., Suite 203
Torrance,  CA  90501
Correspondent Contact RONALD A WALDORF
Regulation Number882.1460
Classification Product Code
GWN  
Date Received10/09/1992
Decision Date 03/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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