Sepsis ImmunoScore is an AI-enabled medical device from Prenosis, Inc., listed by FDA (De Novo, DEN230036) with a decision date of 2024-04-02. Review panel: General Hospital.
| FDA submission number | DEN230036 |
|---|---|
| Pathway | De Novo |
| Company | Prenosis, Inc. |
| Review panel (specialty) | General Hospital |
| FDA decision date | 2024-04-02 |
| Decision | Unknown |
| Product code | SAK |
| Classification | Software Device To Aid In The Prediction Or Diagnosis Of Sepsis |
| Device class | 2 |
| Regulation number | 880.6316 |
| Review time (calendar days) | 333 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All General Hospital AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.