BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS


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

Correspodent Contact eduardo faria
Regulation Number 882.1400
Classification Product Code
GWQ  
Subsequent Product Code
OLV  
Date Received 07/22/2011
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