De Novo
DEN200042: BrainTemp Neonate System (BTNeo System)
FDA De Novo · brain temp inc. · decided Mar 29, 2022
Key facts
| De Novo number | DEN200042 |
|---|---|
| Device name | BrainTemp Neonate System (BTNeo System) |
| Applicant | brain temp inc. |
| Product code | QSL |
| Date received | Jun 23, 2020 |
| Decision date | Mar 29, 2022 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| 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: