510(k) K141752 ยท ODN Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
NXSTAGE SYSTEM ONE
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Dec 19, 2014 |
| Received | Jun 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141752
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.