Eko Analysis Software is an AI-enabled medical device from Eko Devices Inc, listed by FDA (510(k), K192004) with a decision date of 2020-01-15. Review panel: Cardiovascular.
| FDA submission number | K192004 |
|---|---|
| Pathway | 510(k) |
| Company | Eko Devices Inc |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2020-01-15 |
| Decision | Substantially Equivalent |
| Product code | MWI |
| Classification | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Device class | 2 |
| Regulation number | 870.2300 |
| Review time (calendar days) | 173 |
| 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.