HeartKey® Rhythm is an AI-enabled medical device from B-Secur Limited, listed by FDA (510(k), K233755) with a decision date of 2024-08-16. Review panel: Cardiovascular.
| FDA submission number | K233755 |
|---|---|
| Pathway | 510(k) |
| Company | B-Secur Limited |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2024-08-16 |
| Decision | Substantially Equivalent |
| Product code | DQK |
| Classification | Computer, Diagnostic, Programmable |
| Device class | 2 |
| Regulation number | 870.1425 |
| Review time (calendar days) | 268 |
| Applicant country | GB |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.