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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 K103140
Device Name NICOLET WIRELESS EEG
Applicant
Carefusion 209, Inc.
1850 Deming Way
Middleton,  WI  53562
Applicant Contact ROBERT BURDGE
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Code
GWQ  
Date Received10/25/2010
Decision Date 04/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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