De Novo
DEN140016: STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
FDA De Novo · dexcom, inc. · decided Aug 19, 2014
Key facts
| De Novo number | DEN140016 |
|---|---|
| Device name | STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE |
| Applicant | dexcom, inc. |
| Product code | PHV |
| Date received | Apr 22, 2014 |
| Decision date | Aug 19, 2014 |
| Decision | granted (DENG) |
| FDA classification | Class I |
| Review panel | Clinical Chemistry |
| FEI number | 3004753838 |
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: