Santa Ana, CA, US · 4 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| CBK | — | — | — | 3 | 2024-03-01 |
| MNT | Sv70 Ventilator | Class II | Anesthesiology | 1 | 2022-07-01 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-07-20 | Class II | Terminated | Z-2435-2021 | Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Vent… | — | Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 I… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-03-01 | K231778 | Nihon Kohden NKV-550 Series Ventilator System | CBK | — | — |
| 2023-05-31 | K222644 | Nihon Kohden NKV-440 Ventilator System | CBK | — | — |
| 2022-07-01 | K213521 | Nihon Kohden NKV-330 Ventilator System | MNT | Class II | Anesthesiology |
| 2020-01-10 | K192307 | Nihon Kohden NKV-550 Series Ventilator System | CBK | — | — |