FDA 510(k) Application Details - K243566

Device Classification Name	Ballistocardiograph   More FDA Info for this Device
510(K) Number	K243566
Device Name	Ballistocardiograph
Applicant	Cardiosense, Inc. 400 N Aberdeen St. Suite 900 Chicago, IL 60642 US Other 510(k) Applications for this Company
Contact	Arezou Azar Other 510(k) Applications for this Contact
Regulation Number	870.2320   More FDA Info for this Regulation Number
Classification Product Code	DXR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2024
Decision Date	07/22/2025
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