Murrysville, PA, US · 8 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Class II | Anesthesiology | 6 | 2026-09-25 |
| CBK | Ventilator, Continuous, Facility Use | Class II | Anesthesiology | 1 | 2024-12-30 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | Class II | Neurology | 1 | 2020-10-29 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-25 | K261262 | Altis Full Face Mask | BZD | Class II | Anesthesiology |
| 2024-12-30 | K243394 | AF531 Oro-Nasal SE Face Mask | CBK | Class II | Anesthesiology |
| 2023-07-28 | K231313 | Therapy Mask 3100 NC/SP | BZD | Class II | Anesthesiology |
| 2021-08-24 | K210844 | DreamWear Silicone Pillows Mask | BZD | Class II | Anesthesiology |
| 2021-07-12 | K210386 | Magneto Nasal Mask | BZD | Class II | Anesthesiology |
| 2020-10-29 | K202142 | Sleepware G3 | OLZ | Class II | Neurology |
| 2020-09-25 | K201439 | Ventilator, Non-continuous (Respirator) | BZD | Class II | Anesthesiology |
| 2020-07-10 | K200480 | DreamStation 2 System, DreamStation 2 Advanced System | BZD | Class II | Anesthesiology |