FDA 510(k) Application Details - K151219

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K151219
Device Name	System, X-Ray, Stationary
Applicant	BEIJING POLYCON MEDICAL ENGINEERING COMPANY HAI DIAN QU BUILDING 9 FU WAI LIANG JIA DIAN BEIJING 100142 CN Other 510(k) Applications for this Company
Contact	XIANGCHEN LIU Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2015
Decision Date	08/04/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review