FDA 510(k) Application Details - K083639

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K083639
Device Name	Computer, Diagnostic, Programmable
Applicant	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. WAUWATOSA, WI 53226 US Other 510(k) Applications for this Company
Contact	LARRY LEPLEY 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	12/09/2008
Decision Date	02/17/2009
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