De Novo
DEN000004: QUICKAIR CHOKE RELIEVER, MODEL 59-001A
FDA De Novo · maet industries, inc. · decided Feb 29, 2000
Key facts
| De Novo number | DEN000004 |
|---|---|
| Device name | QUICKAIR CHOKE RELIEVER, MODEL 59-001A |
| Applicant | maet industries, inc. |
| Product code | MZT |
| Date received | Jan 28, 2000 |
| Decision date | Feb 29, 2000 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Anesthesiology |
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: