Cupertino, CA, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Class II | Cardiovascular | 1 | 2023-09-29 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-02-24 | Class II | Ongoing | Z-1508-2025 | Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 | — | Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure … |