FDA 510(k) Application Details - K133695

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K133695
Device Name	System, X-Ray, Stationary
Applicant	GEMSS MEDICAL SYSTEMS CO., LTD 8310 BUFFALO SPEEDWAY HOUSTON, TX 77025 US Other 510(k) Applications for this Company
Contact	DAVE KIM 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	12/03/2013
Decision Date	08/07/2014
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