510(k) K191313 ยท QJY Infusion Pump, Drug Specific, Pharmacy-Filled
Unity Subcutaneous Infusion System for Remodulin
| Applicant | DEKA Research & Development, Manchester NH, US |
| Decision | Substantially Equivalent, Feb 21, 2020 |
| Received | May 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191313
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.