510(k) K192860 ยท FRN Pump, Infusion
Sapphire Infusion Pump, Sapphire administration sets
| Applicant | Q Core Medical , Ltd., Netanya, IL |
| Decision | Substantially Equivalent, Nov 19, 2020 |
| Received | Oct 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192860
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2023 | EITAN MEDICAL LTD Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001) Open, Classified |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.