510(k) K231778 ยท CBK Ventilator, Continuous, Facility Use
Nihon Kohden NKV-550 Series Ventilator System
| Applicant | Nihon Kohden Orangemed, LLC, Santa Ana CA, US |
| Decision | Substantially Equivalent, Mar 1, 2024 |
| Received | Jun 16, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231778
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.