Omron BP765CAN (HEM-7311-CACS)

Omron BP765CAN (HEM-7311-CACS)
Device Name:BP765CAN
Device Model:HEM-7311-CACS
Manufacturer:Sole: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600 8530, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
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Assessment:

While the technology used in the Omron BP765CAN (HEM-7311-CACS), 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 AssessmentRecommendationBasis
MedavalNot recommendedThis device has not been clinically validated. Although equivalence to another device is claimed by the manufacturer, this has not been tested scientifically.
Hypertension CanadaGeneral useManufacturer declaration of equivalence