Saranas Early Bird Bleed Monitoring System is an AI-enabled medical device from Saranas Inc., listed by FDA (510(k), K230273) with a decision date of 2023-05-25. Review panel: Cardiovascular.
| FDA submission number | K230273 |
|---|---|
| Pathway | 510(k) |
| Company | Saranas Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2023-05-25 |
| Decision | Substantially Equivalent |
| Product code | QFJ |
| Classification | Intravascular Bleed Monitor |
| Device class | 2 |
| Regulation number | 870.1345 |
| Review time (calendar days) | 114 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.