510(k) K093902 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
| Applicant | Fresenius Medical Care North America, Waltham MA, US |
| Decision | Substantially Equivalent, May 27, 2010 |
| Received | Dec 22, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093902
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2014 | Fresenius Medical Care Holdings, Inc. Fresenius 2008 Series Hemodialysis Machines:
Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T
The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indica Terminated |
KDI | None listed |
| Jul 11, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius Service Replacement 0-Ring.
Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.