physIQ Heart Rhythm and Respiratory Module is an AI-enabled medical device from physIQ, Inc, listed by FDA (510(k), K183322) with a decision date of 2019-07-10. Review panel: Cardiovascular.
| FDA submission number | K183322 |
|---|---|
| Pathway | 510(k) |
| Company | physIQ, Inc |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2019-07-10 |
| Decision | Substantially Equivalent |
| Product code | DPS |
| Classification | Electrocardiograph |
| Device class | 2 |
| Regulation number | 870.2340 |
| Review time (calendar days) | 222 |
| 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.