MATRx plus is an AI-enabled medical device from Zephyr Sleep Technologies, listed by FDA (De Novo, DEN170090) with a decision date of 2018-08-23. Review panel: Dental.
| FDA submission number | DEN170090 |
|---|---|
| Pathway | De Novo |
| Company | Zephyr Sleep Technologies |
| Review panel (specialty) | Dental |
| FDA decision date | 2018-08-23 |
| Decision | Unknown |
| Product code | QCJ |
| Classification | Closed Loop Auto Titration Device For Oral Appliances |
| Device class | 2 |
| Regulation number | 872.5571 |
| Review time (calendar days) | 245 |
| Applicant country | CA |
Official FDA database record · FDA AI-enabled device list
All Dental AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.