FDA 510(k) Application Details - K160065

Device Classification Name	More FDA Info for this Device
510(K) Number	K160065
Device Name	GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
Applicant	GEMSS MEDICAL SYSTEMS CO., LTD 2nd Floor, 29, Dunchon-daero 541 beon-gil, Jungwon-gu Seongnam-si 13216 KR Other 510(k) Applications for this Company
Contact	Sang Woo Lee 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	01/13/2016
Decision Date	05/20/2016
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