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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K120979
Device Name CAREFUSION NICOLET EDX
Applicant
Carefusion 209, Inc.
1850 Deming Way
Middleton,  WI  53562
Applicant Contact CURTIS TRUESDALE
Correspondent
Carefusion 209, Inc.
1850 Deming Way
Middleton,  WI  53562
Correspondent Contact CURTIS TRUESDALE
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GWE   GWJ   GZP   IKN   JXE  
OLT  
Date Received04/02/2012
Decision Date 04/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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