K250258 is an FDA 510(k) clearance for the HeartBeam AIMIGo with 12-L ECG Synthesis Software System. This device is classified as a Transmitters And Receivers, Electrocardiograph, Telephone (Class II - Special Controls, product code DXH).
Submitted by Heartbeam, Inc. (Santa Clara, US). The FDA issued a Cleared decision on December 8, 2025, 314 days after receiving the submission on January 28, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2920.
| 510(k) Number | K250258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2025 |
| Decision Date | December 08, 2025 |
| Days to Decision | 314 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXH — Transmitters And Receivers, Electrocardiograph, Telephone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2920 |