510(k) K191093 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Isopure Dry Acid Dissolution System
| Applicant | Isopure, Corp., Louisville KY, US |
| Decision | Substantially Equivalent, Jan 22, 2020 |
| Received | Apr 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191093
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.