510(k) K131611 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
FRESENIUS DRY ACID DISSOLUTION UNITS
| Applicant | Fresenius Medical Care North America, Waltham MA, US |
| Decision | Substantially Equivalent, Aug 29, 2013 |
| Received | Jun 3, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131611
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2015 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147.
For Use in the Preparation of acid concentrate for hemodialysis. Terminated |
KPO | None listed |
| Oct 23, 2015 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075.
For Use in the Preparation of acid concentrate for hemodialysis. Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.