FDA 510(k) Application Details - K213579

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K213579
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	FONA S.r.l Via G.Galilei 11 Assago 20057 IT Other 510(k) Applications for this Company
Contact	Luigi Germano Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	OAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2021
Decision Date	03/02/2022
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