FDA 510(k) Application Details - K082781

Device Classification Name	More FDA Info for this Device
510(K) Number	K082781
Device Name	OEC 9900 ELITE
Applicant	GE HEALTHCARE SURGERY 384 WRIGHT BROTHERS DRIVE SALT LAKE CITY, UT 84116 US Other 510(k) Applications for this Company
Contact	MARIA C FRAME 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	09/22/2008
Decision Date	05/01/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review