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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 (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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