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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name reduced- montage standard electroencephalograph
510(k) Number K060523
Device Name NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM
Applicant
CYBERKINETICS, INC.
800 LEVANGER LANE
STOUGHTON,  WI  53589
Applicant Contact Gary Syring
Correspondent
CYBERKINETICS, INC.
800 LEVANGER LANE
STOUGHTON,  WI  53589
Correspondent Contact Gary Syring
Regulation Number882.1400
Classification Product Code
OMC  
Date Received02/27/2006
Decision Date 03/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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