FDA 510(k) Application Details - K143494

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K143494
Device Name	System, X-Ray, Mobile
Applicant	DEXCOWIN CO., LTD No. 606, Woolim Lions Valley II 680 GEUMCHUN-GU SEOUL 153-776 KR Other 510(k) Applications for this Company
Contact	Ryu Seung-Bum Other 510(k) Applications for this Contact
Regulation Number	892.1720   More FDA Info for this Regulation Number
Classification Product Code	IZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2014
Decision Date	10/05/2015
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