BIOS Precision 10.0 (3MS1-4K) aka Ultra BD350
Assessment:
While the technology used in the BIOS Precision 10.0 (3MS1-4K) aka Ultra BD350, 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 has not been clinically validated. Although equivalence to another device is claimed by the manufacturer, this has not been tested scientifically. | ||
| Hypertension Canada | General use | Manufacturer declaration of equivalence | ||
