510(k) K093379 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM
| Applicant | Bl Healthcare, Inc., Foxboro MA, US |
| Decision | Substantially Equivalent, Feb 9, 2010 |
| Received | Oct 29, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093379
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.