De Novo
DEN030001: NIOX ARTICLE NO: 02-1000
FDA De Novo · aerocrine ab · decided Apr 30, 2003
Key facts
| De Novo number | DEN030001 |
|---|---|
| Device name | NIOX ARTICLE NO: 02-1000 |
| Applicant | aerocrine ab |
| Product code | MXA |
| Date received | Mar 18, 2003 |
| Decision date | Apr 30, 2003 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Chemistry |
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: