De Novo
DEN170021: SEM Scanner (Model 200)
FDA De Novo · bruin biometrics, llc · decided Dec 20, 2018
Key facts
| De Novo number | DEN170021 |
|---|---|
| Device name | SEM Scanner (Model 200) |
| Applicant | bruin biometrics, llc |
| Product code | QEF |
| Date received | Apr 3, 2017 |
| Decision date | Dec 20, 2018 |
| Decision | granted (DENG) |
| FDA classification | Class I |
| Review panel | Gastroenterology & Urology |
| FEI number | 3009769359 |
At a glance
- None 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: