FDA 510(k) Application Details - K130155

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K130155
Device Name	Computer, Diagnostic, Programmable
Applicant	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 9900 WEST INNOVATION DRIVE WAUWATOSA, WI 53226 US Other 510(k) Applications for this Company
Contact	KRISTIN PABST 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	01/22/2013
Decision Date	03/01/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review