510(k) K121421 ยท ONW Hemodialysis System For Home Use
FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
| Applicant | Fresenius Medical Care North America, Design Cente, Waltham MA, US |
| Decision | Substantially Equivalent, Jan 17, 2013 |
| Received | May 14, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121421
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2015 | Fresenius Medical Care Holdings, Inc. 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYST Terminated |
KDI | None listed |
| Jan 27, 2015 | Fresenius Medical Care Holdings, Inc. ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment
2008K@home Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.