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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 K991054
Device Name BRAVO MULTI-MODALITY SYSTEM
Original Applicant
NICOLET BIOMEDICAL, INC.
5225 verona rd.
madison,  WI  53711
Original Contact douglas e pfrang
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
GWE   GWF   GWJ   IKN   JAF  
OLT  
Date Received03/30/1999
Decision Date 11/03/1999
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
Recalls CDRH Recalls
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