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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K042626
Device Name NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM
Applicant
Cyberkinetics, Inc.
100 Foxboro Blvd. Suite 240
Foxboro,  MA  02035
Applicant Contact BURKE T BARRETT
Correspondent
Cyberkinetics, Inc.
100 Foxboro Blvd. Suite 240
Foxboro,  MA  02035
Correspondent Contact BURKE T BARRETT
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received09/27/2004
Decision Date 03/28/2005
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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