ASSURE Wearable ECG is an AI-enabled medical device from Kestra Medical Technologies, Inc., listed by FDA (510(k), K233864) with a decision date of 2024-05-07. Review panel: Cardiovascular.
| FDA submission number | K233864 |
|---|---|
| Pathway | 510(k) |
| Company | Kestra Medical Technologies, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2024-05-07 |
| Decision | Substantially Equivalent |
| Product code | MWJ |
| Classification | Electrocardiograph, Ambulatory (Without Analysis) |
| Device class | 2 |
| Regulation number | 870.2800 |
| Review time (calendar days) | 153 |
| Applicant country | US |
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.