FDA 510(k) Application Details - K200022

Device Classification Name	More FDA Info for this Device
510(K) Number	K200022
Device Name	FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System
Applicant	LiverMoreTech Inc. 801 North Jupiter Rd, Suite 200 Plano, TX 75074 US Other 510(k) Applications for this Company
Contact	Jae Hong Kim Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/2020
Decision Date	04/03/2020
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