510(k) K032854 ยท FPA Set, Administration, Intravascular
UNOMEDICAL MONICA INFUSION SET
| Applicant | Unomedical A/S, Roskilde, DK |
| Decision | Substantially Equivalent, Oct 9, 2003 |
| Received | Sep 12, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032854
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2022 | Unomedical A/S Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump. Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.