FDA 510(k) Application Details - K231424

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K231424
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	HeartBeam, Inc. 2118 Walsh Avenue Suite 210 Santa Clara, CA 95110 US Other 510(k) Applications for this Company
Contact	Ken Persen Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2023
Decision Date	12/13/2024
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