The following data is part of a De Novo classification by Zephyr Sleep Technologies with the FDA for Matrx Plus.
| DeNovo ID | DEN170090 |
| Device Name: | MATRx Plus |
| Classification | Closed Loop Auto Titration Device For Oral Appliances |
| Applicant | Zephyr Sleep Technologies 610a 70 Ave Se Calgary, CA T2h-2j6 |
| Contact | Sabrina Bruehlmann |
| Product Code | QCJ |
| CFR Regulation Number | 872.5571 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Dental |
| Classification Advisory | Dental |
| Type | Direct |
| Date Received | 2017-12-21 |
| Decision Date | 2018-08-23 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |