Redwood City, CA, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DRG | — | — | — | 1 | 2024-09-26 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-07-19 | Class II | Ongoing | Z-2616-2024 | BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device int… | — | Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification. |