510(k) K993272 ยท FIN Tank, Holding, Dialysis
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
| Applicant | Pure Water, Inc., Anderson SC, US |
| Decision | Substantially Equivalent, Apr 10, 2000 |
| Received | Sep 30, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993272
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2011 | Isopure Corp Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012 Terminated |
FJP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.