FDA 510(k) Application Details - K123238

Device Classification Name	Bone Sonometer   More FDA Info for this Device
510(K) Number	K123238
Device Name	Bone Sonometer
Applicant	GE MEDICAL SYSTEMS CHINA CO., LTD. NO. 19 CHANGJIANG ROAD NATIONAL HI-TECH DEV. ZONE WUXI, JIANGSU PROVINCE 214028 CN Other 510(k) Applications for this Company
Contact	LIU ZHAO Other 510(k) Applications for this Contact
Regulation Number	892.1180   More FDA Info for this Regulation Number
Classification Product Code	MUA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/2012
Decision Date	02/25/2013
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