K231424
- 510(k) number
- K231424
- Device name
- HeartBeam AIMIGo(TM) System
- Applicant
- Heartbeam, Inc. CA · US
- Product code
- MWJ — Electrocardiograph, Ambulatory (Without Analysis)
- Decision date
- 2024-12-13
- Date received
- 2023-05-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K231424.pdf
Official FDA record: K231424
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.