FDA 510(k) Application Details - K231683

Device Classification Name	More FDA Info for this Device
510(K) Number	K231683
Device Name	inHEART Models
Applicant	inHEART, SAS IHU LIryc û H⌠pital Xavier Arnozan-Avenue du Haut LΘvΩque Pessac 33600 FR Other 510(k) Applications for this Company
Contact	Audrey Labeque Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/2023
Decision Date	02/29/2024
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