510(k) K994267 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FRESENIUS 2008K
| Applicant | Fresenius Medical Care, Lexington MA, US |
| Decision | Substantially Equivalent, Mar 16, 2000 |
| Received | Dec 17, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994267
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2015 | Fresenius Medical Care Holdings, Inc. 2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and D Terminated |
KDI | None listed |
| Apr 29, 2015 | Fresenius Medical Care Holdings, Inc. 2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HE 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 |
| 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 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius USA Inc., Walnut Creek, CA Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.