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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 K112052
Device Name CAREFUSION NICOLET EDX
Original Applicant
CAREFUSION 209, INC.
1850 deming way
middleton,  WI  53562
Original Contact robert burdge
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GWE   GWJ   GZP   IKN   JXE  
OLT  
Date Received07/18/2011
Decision Date 03/15/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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