MIMOSA Imager is an AI-enabled medical device from MIMOSA Diagnostics Inc, listed by FDA (510(k), K190334) with a decision date of 2019-11-01. Review panel: Cardiovascular.
| FDA submission number | K190334 |
|---|---|
| Pathway | 510(k) |
| Company | MIMOSA Diagnostics Inc |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2019-11-01 |
| Decision | Substantially Equivalent |
| Product code | MUD |
| Classification | Oximeter, Tissue Saturation |
| Device class | 2 |
| Regulation number | 870.2700 |
| Review time (calendar days) | 260 |
| Applicant country | CA |
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.