De Novo
DEN040007: VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
FDA De Novo · digital angel corporation · decided Oct 12, 2004
Key facts
| De Novo number | DEN040007 |
|---|---|
| Device name | VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER |
| Applicant | digital angel corporation |
| Product code | NRV |
| Date received | Aug 4, 2004 |
| Decision date | Oct 12, 2004 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General Hospital |
| FEI number | 3003309171 |
At a glance
- 1–9 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: