K250258
- 510(k) number
- K250258
- Device name
- HeartBeam AIMIGo with 12-L ECG Synthesis Software System
- Applicant
- Heartbeam, Inc. CA · US
- Product code
- DXH — Transmitters And Receivers, Electrocardiograph, Tele
- Decision date
- 2025-12-08
- Date received
- 2025-01-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250258.pdf
Official FDA record: K250258
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.