510(k) K180045 ยท LZG Pump, Infusion, Insulin
Omnipod DASH Insulin Management System
| Applicant | Insulet Corporation, Billerica MA, US |
| Decision | Substantially Equivalent, Jun 1, 2018 |
| Received | Jan 8, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180045
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2018 | Insulet Corporation Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1 Terminated |
LZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.