Abbotsford, AU · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MNR | Ventilatory Effort Recorder | Class II | Anesthesiology | 2 | 2025-08-28 |
| OLV | Standard Polysomnograph With Electroencephalograph | Class II | Neurology | 1 | 2025-02-20 |
| GWQ | Full-Montage Standard Electroencephalograph | Class II | Neurology | 1 | 2023-02-09 |
| OLY | Magnetoencephalograph | Class II | Neurology | 1 | 2020-02-14 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-08-28 | K252383 | Somfit D | MNR | Class II | Anesthesiology |
| 2025-02-20 | K242447 | Falcon HST | OLV | Class II | Neurology |
| 2023-11-30 | K231546 | Somfit | MNR | Class II | Anesthesiology |
| 2023-02-09 | K230073 | Okti | GWQ | Class II | Neurology |
| 2020-02-14 | K191785 | Orion LifeSpan MEG | OLY | Class II | Neurology |