510(k) K191679 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Omnipod DASH Insulin Management System with interoperable technology
| Applicant | Insulet Corporation, Acton MA, US |
| Decision | Substantially Equivalent, Sep 20, 2019 |
| Received | Jun 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191679
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.