FDA 510(k) Application Details - K202235

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K202235
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	CMT Medical Technologies Ltd 7/2 Hacarmel St., POB 111, Industrial Park Yokneam Ilit 20692 IL Other 510(k) Applications for this Company
Contact	Dror Wertman Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	JAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2020
Decision Date	09/03/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review