De Novo
DEN180067: Mucosal Integrity Conductivity (MI) Test System
FDA De Novo · diversatek healthcare inc. · decided Dec 23, 2019
Key facts
| De Novo number | DEN180067 |
|---|---|
| Device name | Mucosal Integrity Conductivity (MI) Test System |
| Applicant | diversatek healthcare inc. |
| Product code | QIS |
| Date received | Dec 17, 2018 |
| Decision date | Dec 23, 2019 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Gastroenterology & Urology |
| FEI number | 2023374 |
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: