EndoTool SubQ is an AI-enabled medical device from MONARCH MEDICAL TECHNOLOGIES, listed by FDA (510(k), K142918) with a decision date of 2015-04-24. Review panel: Anesthesiology.
| FDA submission number | K142918 |
|---|---|
| Pathway | 510(k) |
| Company | MONARCH MEDICAL TECHNOLOGIES |
| Review panel (specialty) | Anesthesiology |
| FDA decision date | 2015-04-24 |
| Decision | Substantially Equivalent |
| Product code | NDC |
| Classification | Calculator, Drug Dose |
| Device class | 2 |
| Regulation number | 868.1890 |
| Review time (calendar days) | 199 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Anesthesiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.