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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Photic, Evoked Response
510(k) Number K101763
Device Name DIOPSYS NOVA VEP VISION TESTING SYSTEM
Applicant
Diopsys, Inc.
44 Countrywood Dr.
Pine Brook,  NJ  07058
Applicant Contact RICHARD HETTENBACH
Correspondent
Diopsys, Inc.
44 Countrywood Dr.
Pine Brook,  NJ  07058
Correspondent Contact RICHARD HETTENBACH
Regulation Number882.1890
Classification Product Code
GWE  
Date Received06/23/2010
Decision Date 05/09/2011
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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