510(k) K231918 ยท FRN Pump, Infusion
Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter
| Applicant | Koru Medical Systems, Mahwah NJ, US |
| Decision | Substantially Equivalent, Nov 3, 2023 |
| Received | Jun 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231918
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.