Colin BP-608EV
Assessment:
While the technology used in the Colin BP-608EV, to measure blood pressure, has been claimed as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.
Accuracy Assessment | Recommendation | Basis | ||
---|---|---|---|---|
Medaval | Not recommended | This device has not shown to have been clinically validated. | ||
Japanese Society of Hypertension | Professional use (2016-2018) | Implied equivalence to the Omron M3500 NIBP Module |
Device Family:Colin BP-608EVJ, Colin BP-A308J, Colin BP-A308DJ, Colin HBP-2070J, Colin HBP-2071J (J JHS Implied Equivalence)