FDA 510(k) Application Details - K140380

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K140380
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	GENERAL MEDICAL MERATE S.P.A. 110 E. GRANADA BLVD SUITE 209 ORMOND BEACH, FL 32176 US Other 510(k) Applications for this Company
Contact	BERTHOIN CLAUDE 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	02/14/2014
Decision Date	09/26/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review