FDA 510(k) Application Details - K043076

Device Classification Name	More FDA Info for this Device
510(K) Number	K043076
Device Name	GE OEC FLUOROSTAR
Applicant	GE OEC MEDICAL SYSTEMS, INC. 384 WRIGHT BROTHERS DR. SALT LAKE CITY, UT 84116 US Other 510(k) Applications for this Company
Contact	JEFF WAGNER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2004
Decision Date	12/22/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review