FDA 510(k) Application Details - K243614

Device Classification Name	More FDA Info for this Device
510(K) Number	K243614
Device Name	Sonio Suspect
Applicant	Sonio 17 rue du Faubourg Montmartre Paris 75009 FR Other 510(k) Applications for this Company
Contact	Florian Akpakpa Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2024
Decision Date	02/21/2025
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