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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K250258
Device Name HeartBeam AIMIGo with 12-L ECG Synthesis Software System
Applicant
Heartbeam, Inc.
2118 Walsh Rd., Suite 210
Santa Clara,  CA  95110
Applicant Contact Deborah Castillo
Correspondent
Heartbeam, Inc.
2118 Walsh Rd., Suite 210
Santa Clara,  CA  95110
Correspondent Contact Deborah Castillo
Regulation Number870.2920
Classification Product Code
DXH  
Date Received01/28/2025
Decision Date 12/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT06123130
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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