510(k) K141389 ยท FRN Pump, Infusion
SAPPHIRE INFUSION PUMP
| Applicant | Q Core Medical , Ltd., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Dec 11, 2014 |
| Received | May 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141389
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.