BIOS BD350 aka 3MS1-4K aka Ultra (Precision 10.0)
Assessment:
While the technology used in the BIOS BD350 aka 3MS1-4K aka Ultra (Precision 10.0), to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | Not recommended | This device failed clinical validation. | ||
| Hypertension Canada | Self-measurement (Gold) | Manufacturer declaration of equivalence | ||
