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Heartbeam, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemDecember 8, 2025
K231424HeartBeam AIMIGo(TM) SystemDecember 13, 2024