New Taipei City, TW · 3 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PZI | Prescription Use Blood Glucose Meter For Near-Patient Testing | Class II | Clinical Chemistry | 1 | 2024-11-19 |
| NBW | System, Test, Blood Glucose, Over The Counter | Class II | Clinical Chemistry | 1 | 2022-06-16 |
| FLL | Continuous Measurement Thermometer | Class II | General Hospital | 1 | 2022-04-05 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-11-19 | K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring System | PZI | Class II | Clinical Chemistry |
| 2022-06-16 | K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System | NBW | Class II | Clinical Chemistry |
| 2022-04-05 | K200946 | Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241) | FLL | Class II | General Hospital |