FDA 510(k) Application Details - K123603

Device Classification Name	More FDA Info for this Device
510(K) Number	K123603
Device Name	OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
Applicant	GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC 384 WRIGHT BROTHERS DRIVE SALT LAKE CITY, UT 84116 US Other 510(k) Applications for this Company
Contact	GERALD BUSS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2012
Decision Date	05/17/2013
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