AI-ECG Tracker is an AI-enabled medical device from Shenzhen Carewell Electronics Co., Ltd., listed by FDA (510(k), K200036) with a decision date of 2020-03-20. Review panel: Cardiovascular.
| FDA submission number | K200036 |
|---|---|
| Pathway | 510(k) |
| Company | Shenzhen Carewell Electronics Co., Ltd. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2020-03-20 |
| Decision | Substantially Equivalent |
| Product code | DPS |
| Classification | Electrocardiograph |
| Device class | 2 |
| Regulation number | 870.2340 |
| Review time (calendar days) | 72 |
| Applicant country | CN |
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.