FDA 510(k) Application Details - K203010

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K203010
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	Apelem-DMS Group Parc Scientifique Georges Besse 175 Alle Von Neumann Nimes 30005 FR Other 510(k) Applications for this Company
Contact	Samuel Sancerni 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	10/01/2020
Decision Date	01/22/2021
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