510(k) K250258

HeartBeam AIMIGo with 12-L ECG Synthesis Software System by Heartbeam, Inc. — Product Code DXH

K250258 is an FDA 510(k) premarket notification submitted by Heartbeam, Inc. for the device "HeartBeam AIMIGo with 12-L ECG Synthesis Software System". The FDA issued a decision of Substantially Equivalent on December 8, 2025. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Heartbeam, Inc. has at least 1 other 510(k) clearance on record.