510(k) K192307 ยท CBK Ventilator, Continuous, Facility Use
Nihon Kohden NKV-550 Series Ventilator System
| Applicant | Nihon Kohden Orangemed, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Jan 10, 2020 |
| Received | Aug 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192307
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2021 | NIHON KOHDEN ORANGEMED, INC Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012
The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.