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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K871678
Device Name NICOLET AMP 6R11 SYSTEM
Applicant
NICOLET BIOMEDICAL INSTRUMENTS
5225-4 VERONA RD.
P.O. BOX 4287
MADISON,  WI  53711
Applicant Contact LUICH, PE
Correspondent
NICOLET BIOMEDICAL INSTRUMENTS
5225-4 VERONA RD.
P.O. BOX 4287
MADISON,  WI  53711
Correspondent Contact LUICH, PE
Regulation Number882.1835
Classification Product Code
GWL  
Date Received04/28/1987
Decision Date 07/16/1987
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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