FDA 510(k) Application Details - K111200

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K111200
Device Name	Computer, Diagnostic, Programmable
Applicant	GE HEALTHCARE 8200 WEST TOWER AVE MILWAUKEE, WI 53223 US Other 510(k) Applications for this Company
Contact	CAROL ALLOIAN Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/2011
Decision Date	10/12/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review