510(k) K040489 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
AQUADEX SYSTEM 100, MODEL A1100
| Applicant | Chf Solutions, Inc., Brooklyn Park MN, US |
| Decision | Substantially Equivalent, Apr 27, 2004 |
| Received | Feb 26, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040489
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.