FDA 510(k) Application Details - K052039

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K052039
Device Name	System, X-Ray, Angiographic
Applicant	GE OEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. SALT LAKE CITY, UT 84116 US Other 510(k) Applications for this Company
Contact	SUSAN SCHMIDT Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2005
Decision Date	08/11/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review