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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 K122196
Model CBS-XX-YYY, WHERE CBS = CERVELLO BIO-POTENTIAL SYSTEM, XX = HARDWARE PLATFORM. VALUES = AM, BA, EL, YYY = NUMBER OF CHAN
Device Name CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY
Original Applicant
BLACKROCK NEUROMED, LLC
117 west south street
oconomowoc,  WI  53066
Original Contact john ziobro
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
GWK   GWL   OLV  
Date Received07/24/2012
Decision Date 05/02/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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