FDA 510(k) Application Details - K234141

Device Classification Name	More FDA Info for this Device
510(K) Number	K234141
Device Name	AISAP Cardio V1.0
Applicant	Aisap The Heart Center, Sheba Medical Center Tel Hashomer Ramat Gan 52621 IL Other 510(k) Applications for this Company
Contact	Robert Klempfner 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	12/29/2023
Decision Date	08/01/2024
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