FDA 510(k) Application Details - K133664

Device Classification Name	Densitometer, Bone   More FDA Info for this Device
510(K) Number	K133664
Device Name	Densitometer, Bone
Applicant	GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN 3030 OHMEDA DRIVE MADISON, WI 53718-6704 US Other 510(k) Applications for this Company
Contact	CHRIS PAULIK Other 510(k) Applications for this Contact
Regulation Number	892.1170   More FDA Info for this Regulation Number
Classification Product Code	KGI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/29/2013
Decision Date	05/15/2014
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