FDA 510(k) Application Details - K071570

Device Classification Name	Densitometer, Bone   More FDA Info for this Device
510(K) Number	K071570
Device Name	Densitometer, Bone
Applicant	GE MEDICAL SYSTEMS LUNAR 726 HEARTLAND TRAIL MADISON, WI 53717 US Other 510(k) Applications for this Company
Contact	JAMES P RASKOB 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	06/08/2007
Decision Date	06/27/2007
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	Y
Expedited Review