De Novo
DEN990005: THE 3PM EGG MACHINE
FDA De Novo · 3pm co., inc. · decided Aug 20, 1999
Key facts
| De Novo number | DEN990005 |
|---|---|
| Device name | THE 3PM EGG MACHINE |
| Applicant | 3pm co., inc. |
| Product code | MYE |
| Date received | Jul 12, 1999 |
| Decision date | Aug 20, 1999 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Gastroenterology & Urology |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- 1–9 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: