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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 K081591
Device Name NEUCODIA
Applicant
VERISCI CORPORATION
106 ANDERSON STREET
RARITAN,  NJ  08869 -1514
Applicant Contact GEORGE HU
Correspondent
VERISCI CORPORATION
106 ANDERSON STREET
RARITAN,  NJ  08869 -1514
Correspondent Contact GEORGE HU
Regulation Number882.1890
Classification Product Code
GWE  
Date Received06/06/2008
Decision Date 05/15/2009
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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