510(k) K921456 ยท FKP System, Dialysate Delivery, Single Patient
FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM
| Applicant | Fresenius USA, Inc., Walnut Creek CA, US |
| Decision | Substantially Equivalent, Apr 20, 1994 |
| Received | Mar 27, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921456
| 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 |
| Aug 15, 2010 | Fresenius Medical Care North America Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA Terminated |
FKP | None listed |
| Aug 15, 2010 | Fresenius Medical Care North America Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA Terminated |
FKP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.