510(k) K162225 ยท MRZ Accessories, Pump, Infusion
WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System
| Applicant | Welldoc, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Nov 22, 2016 |
| Received | Aug 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162225
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.