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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 K112107
Model PV2006E, PV2007E, PV2008E, PV2009E
Device Name BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS
Original Applicant
NEUROVIRTUAL USA, INC.
2315 nw 107th ave
suite #1m27
doral,  FL  33172
Original Contact eduardo faria
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
OLV  
Date Received07/22/2011
Decision Date 10/28/2011
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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