De Novo
DEN230050: Body Temperature Software (BTS)
FDA De Novo · fitbit llc · decided Dec 15, 2023
Key facts
| De Novo number | DEN230050 |
|---|---|
| Device name | Body Temperature Software (BTS) |
| Applicant | fitbit llc |
| Product code | QZA |
| Date received | Jul 17, 2023 |
| Decision date | Dec 15, 2023 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General Hospital |
| FEI number | 3009253624 |
At a glance
- 1–9 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: