FDA 510(k) Application Details - K242129

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K242129
Device Name	Computer, Diagnostic, Programmable
Applicant	VitalConnect, Inc. 2870 Zanker Road Suite 100 San Jose, CA 95134 US Other 510(k) Applications for this Company
Contact	Gabriel Nallathambi 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	07/22/2024
Decision Date	04/17/2025
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