CAREFUSION NICOLET EDX


Device Classification Name

stimulator, electrical, evoked response

510(k) Number K112052
Device Name CAREFUSION NICOLET EDX
Applicant
CAREFUSION 209, INC.
1850 deming way
middleton, 
WI 
53562

Applicant Contact robert burdge
Correspondent
CAREFUSION 209, INC.
1850 deming way
middleton, 
WI 
53562

Correspodent Contact robert burdge
Regulation Number 882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GWE   GWJ   GZP   IKN   JXE  
OLT  
Date Received 07/18/2011
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