AT-Patch (ATP-C130/ATP-C70) is an AI-enabled medical device from ATsens Co.,Ltd., listed by FDA (510(k), K242583) with a decision date of 2025-05-02. Review panel: Cardiovascular.
| FDA submission number | K242583 |
|---|---|
| Pathway | 510(k) |
| Company | ATsens Co.,Ltd. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-05-02 |
| Decision | Substantially Equivalent |
| Product code | DSH |
| Classification | Recorder, Magnetic Tape, Medical |
| Device class | 2 |
| Regulation number | 870.2800 |
| Review time (calendar days) | 245 |
| Applicant country | KR |
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.