AI-ECG Platform is an AI-enabled medical device from Shenzhen Carewell Electronics., Ltd, listed by FDA (510(k), K180432) with a decision date of 2018-11-19. Review panel: Cardiovascular.
| FDA submission number | K180432 |
|---|---|
| Pathway | 510(k) |
| Company | Shenzhen Carewell Electronics., Ltd |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2018-11-19 |
| Decision | Substantially Equivalent |
| Product code | DQK |
| Classification | Computer, Diagnostic, Programmable |
| Device class | 2 |
| Regulation number | 870.1425 |
| Review time (calendar days) | 272 |
| 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.