FDA 510(k) Application Details - K232410

Device Classification Name	More FDA Info for this Device
510(K) Number	K232410
Device Name	SmartChest
Applicant	Milvue 29 Rue du Faubourg Saint Jacques Paris 75014 FR Other 510(k) Applications for this Company
Contact	Oumaya Ibrahim Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2023
Decision Date	05/10/2024
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