510(k) K222318 ยท FKX System, Peritoneal, Automatic Delivery
Fresenius Liberty Select Cycler
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Oct 31, 2022 |
| Received | Aug 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 26, 2023 | Fresenius Medical Care Holdings, Inc. Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111 Open, Classified |
FKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.