De Novo
DEN230021: ensoETM
FDA De Novo · advanced cooling therapy, inc. d/b/a attune medical · decided Sep 13, 2023
Key facts
| De Novo number | DEN230021 |
|---|---|
| Device name | ensoETM |
| Applicant | advanced cooling therapy, inc. d/b/a attune medical |
| Product code | QXV |
| Date received | Mar 30, 2023 |
| Decision date | Sep 13, 2023 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Cardiovascular |
| FEI number | 3010412492 |
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: