De Novo
DEN180024: Leica FL400
FDA De Novo · leica microsystems (schweiz) ag · decided Mar 28, 2019
Key facts
| De Novo number | DEN180024 |
|---|---|
| Device name | Leica FL400 |
| Applicant | leica microsystems (schweiz) ag |
| Product code | QFX |
| Date received | Apr 27, 2018 |
| Decision date | Mar 28, 2019 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Neurology |
| FEI number | 3003974370 |
At a glance
- 1–9 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: