De Novo
DEN170028: Cala ONE
FDA De Novo · cala health, inc. · decided Apr 26, 2018
Key facts
| De Novo number | DEN170028 |
|---|---|
| Device name | Cala ONE |
| Applicant | cala health, inc. |
| Product code | QBC |
| Date received | May 17, 2017 |
| Decision date | Apr 26, 2018 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Neurology |
| FEI number | 3011628389 |
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: