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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conditioner, Signal, Physiological
510(k) Number K843598
Device Name BRAIN FUNCTION MAPPING OPTION FOR PATHF
Applicant
NICOLET BIOMEDICAL INSTRUMENTS
P.O. BOX 4287
MADISON,  WI  53711 -
Applicant Contact RON LUICH
Correspondent
NICOLET BIOMEDICAL INSTRUMENTS
P.O. BOX 4287
MADISON,  WI  53711 -
Correspondent Contact RON LUICH
Regulation Number882.1845
Classification Product Code
GWK  
Date Received09/12/1984
Decision Date 04/11/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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