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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 K131335
Device Name BWMINI EEG, BWMINIHST, BWMINI PSG
Applicant
NEUROVIRTUAL USA, INC.
2315 NW 107TH AVE STE 1M27
DORAL,  FL  33172
Applicant Contact EDUARDO FARIA
Correspondent
NEUROVIRTUAL USA, INC.
2315 NW 107TH AVE STE 1M27
DORAL,  FL  33172
Correspondent Contact EDUARDO FARIA
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
OLV  
Date Received05/09/2013
Decision Date 02/03/2015
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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