FDA 510(k) Application Details - K243312

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K243312
Device Name	Computer, Diagnostic, Programmable
Applicant	CardioCalm Srl Corso Martiri della Libertα, nr. 40 Montichiari 25018 IT Other 510(k) Applications for this Company
Contact	Fabio Badilini Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/2024
Decision Date	02/20/2025
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