Exeter, NH, US · 4 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Class II | Anesthesiology | 2 | 2026-04-13 |
| QAV | High Flow/High Velocity Humidified Oxygen Delivery Device | Class II | Anesthesiology | 1 | 2022-12-13 |
| CAF | Nebulizer (Direct Patient Interface) | Class II | Anesthesiology | 1 | 2022-10-28 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-12-16 | Class II | Ongoing | Z-1272-2023 | Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW | — | There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow Syste… |