Mountain Ash, GB · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Class II | Anesthesiology | 1 | 2026-01-16 |
| BTR | — | — | — | 1 | 2025-05-20 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | Class II | Anesthesiology | 1 | 2020-11-13 |
| CAH | — | — | — | 1 | 2020-03-23 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-16 | K251448 | FL-10000U Respiratory Humidifier | BTT | Class II | Anesthesiology |
| 2025-05-20 | K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) | BTR | — | — |
| 2020-11-13 | K201666 | SINGLE USE MANOMETER | CAP | Class II | Anesthesiology |
| 2020-03-23 | K191909 | HepaShield Bacterial Viral Breathing System Filter | CAH | — | — |