FDA 510(k) Application Details - K222938

Device Classification Name	More FDA Info for this Device
510(K) Number	K222938
Device Name	Ablation-fit
Applicant	R.A.W. Srl Via Soperga 13 Milan 20127 IT Other 510(k) Applications for this Company
Contact	Chiara Ferrari Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2022
Decision Date	09/12/2023
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