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Heartbeam, Inc.

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories2
Latest FDA decision2025-12-08

SEC Filings: 1 filings on record. Latest: 424B5 (2026-08-14). View on SEC EDGAR →

TypeNumberDevice NameCodeDateActions
510(k) K250258 HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemDXH2025-12-08 View
510(k) K231424 HeartBeam AIMIGo(TM) SystemMWJ2024-12-13 View
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