De Novo
DEN060002: INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM
FDA De Novo · inrange systems, inc. · decided Jun 13, 2007
Key facts
| De Novo number | DEN060002 |
|---|---|
| Device name | INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM |
| Applicant | inrange systems, inc. |
| Product code | NZH |
| Date received | Sep 21, 2006 |
| Decision date | Jun 13, 2007 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General Hospital |
At a glance
- None 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: