FDA 510(k) Application Details - K140332

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K140332
Device Name	System, X-Ray, Stationary
Applicant	SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU SUWON-SI, GYEONGGI-DO 443742 KR Other 510(k) Applications for this Company
Contact	AEYOUNG HA 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	02/10/2014
Decision Date	05/28/2014
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