510(k) K232926 ยท QJZ Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
Novalung ultimate kit (US)
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Apr 15, 2024 |
| Received | Sep 20, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232926
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.