510(k) K213521 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Nihon Kohden NKV-330 Ventilator System
| Applicant | Nihon Kohden Orangemed, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Jul 1, 2022 |
| Received | Nov 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213521
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.