De Novo
DEN210006: Hemolung Respiratory Assist System
FDA De Novo · alung technologies, inc. · decided Nov 13, 2021
Key facts
| De Novo number | DEN210006 |
|---|---|
| Device name | Hemolung Respiratory Assist System |
| Applicant | alung technologies, inc. |
| Product code | QOH |
| Date received | Mar 4, 2021 |
| Decision date | Nov 13, 2021 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Cardiovascular |
| FEI number | 3009763347 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- 100–999 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: