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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
Applicant
NICOLET BIOMEDICAL, INC.
5225 VERONA RD.
MADISON,  WI  53711
Applicant Contact DOUGLAS E PFRANG
Correspondent
NICOLET BIOMEDICAL, INC.
5225 VERONA RD.
MADISON,  WI  53711
Correspondent 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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