510(k) K030470 ยท FII System, Dialysate Delivery, Sealed
NXSTAGE SYSTEM ONE
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Jul 7, 2003 |
| Received | Feb 12, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030470
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.