510(k) K222727 ยท NHV System, Water Purification, General Medical Use
i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)
| Applicant | I3 Membrane GmbH, Radeberg, DE |
| Decision | Substantially Equivalent, Jun 2, 2023 |
| Received | Sep 8, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222727
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.