Rooti Rx ECG Event Recorder, Rooti Link APP Software is an AI-enabled medical device from Rooti Labs Ltd., listed by FDA (510(k), K163694) with a decision date of 2017-11-07. Review panel: Cardiovascular.
| FDA submission number | K163694 |
|---|---|
| Pathway | 510(k) |
| Company | Rooti Labs Ltd. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2017-11-07 |
| Decision | Substantially Equivalent |
| Product code | DRG |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device class | 2 |
| Regulation number | 870.2910 |
| Review time (calendar days) | 314 |
| Applicant country | TW |
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.