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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
Predetermined Change
Control Plan Authorized		 No
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