510(k) K181991 ยท FKP System, Dialysate Delivery, Single Patient
NxStage Connected Health System
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Sep 26, 2018 |
| Received | Jul 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181991
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.