De Novo
DEN050007: HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL
FDA De Novo · fmg innovations, inc. · decided Mar 27, 2006
Key facts
| De Novo number | DEN050007 |
|---|---|
| Device name | HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL |
| Applicant | fmg innovations, inc. |
| Product code | NRK |
| Date received | Jun 20, 2005 |
| Decision date | Mar 27, 2006 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Ear, Nose, & Throat |
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: