De Novo
DEN170090: MATRx plus
FDA De Novo · zephyr sleep technologies · decided Aug 23, 2018
Key facts
| De Novo number | DEN170090 |
|---|---|
| Device name | MATRx plus |
| Applicant | zephyr sleep technologies |
| Product code | QCJ |
| Date received | Dec 21, 2017 |
| Decision date | Aug 23, 2018 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Dental |
| FEI number | 3008960597 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: