Dongguan, CN · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Class II | Cardiovascular | 4 | 2025-09-03 |
| FLL | Continuous Measurement Thermometer | Class II | General Hospital | 1 | 2020-11-23 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-09-03 | K250231 | Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) | DXN | Class II | Cardiovascular |
| 2020-11-23 | K193621 | Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) | FLL | Class II | General Hospital |
| 2020-07-12 | K193628 | AGE Automatic Wrist Blood Pressure Monitor | DXN | Class II | Cardiovascular |
| 2020-07-12 | K193627 | Automatic Upper Arm Blood Pressure Monitor | DXN | Class II | Cardiovascular |
| 2020-07-10 | K193624 | Automatic Upper Arm Blood Pressure Monitor | DXN | Class II | Cardiovascular |