San Jose, CA, US · 3 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DRG | — | — | — | 2 | 2020-04-20 |
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | 1 | 2025-04-17 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-05-21 | Class II | Terminated | Z-2537-2020 | VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professional… | — | A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but n… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-04-17 | K242129 | VitalRhythm | DQK | Class II | Cardiovascular |
| 2020-04-20 | K193343 | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) | DRG | — | — |
| 2020-02-06 | K192757 | VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20 | DRG | — | — |