FDA 510(k) Application Details - K240653

Device Classification Name	More FDA Info for this Device
510(K) Number	K240653
Device Name	SmartCardia 7L Platform (MCT)
Applicant	SmartCardia SA EPFL Innovation Park Building C Lausanne 1015 CH Other 510(k) Applications for this Company
Contact	Srinivasan Murali Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2024
Decision Date	10/31/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review