FDA 510(k) Application Details - K250747

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K250747
Device Name	Computer, Diagnostic, Programmable
Applicant	Kardium Inc. 8518 Glenlyon Parkway, Unit 155 Burnaby V5J OB6 CA Other 510(k) Applications for this Company
Contact	Ricardo Romero 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	03/12/2025
Decision Date	06/25/2025
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