FDA 510(k) Application Details - K161131

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K161131
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	FONA SRL VIA GALILEO GALILEI 11 ASSAGO 20090 IT Other 510(k) Applications for this Company
Contact	ELISA GUSBERTI Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	MUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2016
Decision Date	11/03/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review