510(k) K211035 ยท FIP Subsystem, Water Purification
U9000 Plus Ultrafilter
| Applicant | Baxter Healthcare Corporation, Round Lake IL, US |
| Decision | Substantially Equivalent, Oct 19, 2021 |
| Received | Apr 7, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211035
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.