510(k) K080587 ยท MRZ Accessories, Pump, Infusion
EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE
| Applicant | Animas Corp., West Chester PA, US |
| Decision | Substantially Equivalent, May 15, 2008 |
| Received | Mar 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080587
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2009 | Animas Corporation Animas ezManager Max Diabetes Management System version 2.0.9 Terminated |
MRZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.