510(k) K220935 ยท FKX System, Peritoneal, Automatic Delivery
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
| Applicant | Iren-Medical, Ltd., Or Aquiva, IL |
| Decision | Substantially Equivalent, Dec 29, 2022 |
| Received | Mar 31, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220935
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.