De Novo
DEN110002: SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT
FDA De Novo · steris corporation · decided Mar 30, 2012
Key facts
| De Novo number | DEN110002 |
|---|---|
| Device name | SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT |
| Applicant | steris corporation |
| Product code | OVY |
| Date received | Aug 1, 2011 |
| Decision date | Mar 30, 2012 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General Hospital |
| FEI number | 1527821 |
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: