Gaithersburg, MD, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DWJ | System, Thermal Regulating | Class II | Cardiovascular | 3 | 2023-10-24 |
| FXX | — | — | — | 1 | 2021-03-30 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-10-24 | K232638 | FilteredFlo Warming Blankets | DWJ | Class II | Cardiovascular |
| 2023-06-30 | K231596 | IOB Temperature Management System | DWJ | Class II | Cardiovascular |
| 2022-12-27 | K221669 | IOB Warming Blankets | DWJ | Class II | Cardiovascular |
| 2021-03-30 | K201896 | ivi N3003 Surgical face Mask, ivi N6006 Surgical mask | FXX | — | — |