d-Nav System is an AI-enabled medical device from Hygieia, Inc, listed by FDA (510(k), K181916) with a decision date of 2019-02-04. Review panel: Anesthesiology.
| FDA submission number | K181916 |
|---|---|
| Pathway | 510(k) |
| Company | Hygieia, Inc |
| Review panel (specialty) | Anesthesiology |
| FDA decision date | 2019-02-04 |
| Decision | Substantially Equivalent |
| Product code | NDC |
| Classification | Calculator, Drug Dose |
| Device class | 2 |
| Regulation number | 868.1890 |
| Review time (calendar days) | 202 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Anesthesiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.