De Novo
DEN150004: EPIC ClearView System
FDA De Novo · epic research & diagnostics, inc. · decided Jul 15, 2016
Key facts
| De Novo number | DEN150004 |
|---|---|
| Device name | EPIC ClearView System |
| Applicant | epic research & diagnostics, inc. |
| Product code | PNA |
| Date received | Jan 13, 2015 |
| Decision date | Jul 15, 2016 |
| Decision | granted (DENG) |
| FDA classification | Class I |
| Review panel | Neurology |
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: