WellDoc BlueStar is an AI-enabled medical device from WellDoc, Inc., listed by FDA (510(k), K190013) with a decision date of 2019-11-04. Review panel: General Hospital.
| FDA submission number | K190013 |
|---|---|
| Pathway | 510(k) |
| Company | WellDoc, Inc. |
| Review panel (specialty) | General Hospital |
| FDA decision date | 2019-11-04 |
| Decision | Substantially Equivalent |
| Product code | MRZ |
| Classification | Accessories, Pump, Infusion |
| Device class | 2 |
| Regulation number | 880.5725 |
| Review time (calendar days) | 305 |
| 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.