FDA 510(k) Application Details - K250160

Device Classification Name	More FDA Info for this Device
510(K) Number	K250160
Device Name	ANKYRAS
Applicant	Mentice Spain S.L. Rambla Catalunya, 53-55 Barcelona 08007 ES Other 510(k) Applications for this Company
Contact	HΘctor Fernßndez Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2025
Decision Date	05/06/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review