De Novo
DEN100025: WIDEXLINK IN CLEAR SERIES HEARING AIDS
FDA De Novo · office research in clinical amplifiction · decided Mar 31, 2011
Key facts
| De Novo number | DEN100025 |
|---|---|
| Device name | WIDEXLINK IN CLEAR SERIES HEARING AIDS |
| Applicant | office research in clinical amplifiction |
| Product code | OSM |
| Date received | Oct 13, 2010 |
| Decision date | Mar 31, 2011 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Ear, Nose, & Throat |
At a glance
- None Later 510(k)s citing this De Novo
- None 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: