510(k) K112427 ยท FIN Tank, Holding, Dialysis
BICARB MIXING AND DISTRIBUTION SYSTEM
| Applicant | Isopure, Corp., Simpsonville KY, US |
| Decision | Substantially Equivalent, Jan 26, 2012 |
| Received | Aug 23, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112427
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2022 | Isopure Corp Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) Open, Classified |
FIN | None listed |
| Jan 19, 2020 | Isopure Corp Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3 Terminated |
FIN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.