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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
Device Name BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS
Applicant
NEUROVIRTUAL USA, INC.
2315 NW 107TH AVE
SUITE #1M27
DORAL,  FL  33172
Applicant Contact EDUARDO FARIA
Correspondent
NEUROVIRTUAL USA, INC.
2315 NW 107TH AVE
SUITE #1M27
DORAL,  FL  33172
Correspondent 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 (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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