FDA 510(k) Application Details - K160131

Device Classification Name	More FDA Info for this Device
510(K) Number	K160131
Device Name	OEC Elite MiniView
Applicant	GE HANGWEI MEDICAL SYSTEMS CO., LTD. NO.1 YONGCHANG NORTH ROAD, BEIJING ECON.&TECH.DEV.ZONE BEIJING 100176 CN Other 510(k) Applications for this Company
Contact	LIFENG WANG 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	01/20/2016
Decision Date	06/21/2016
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