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Omron M7 Intelli IT (HEM-7322T-E)

Device Name:M7 Intelli IT
Device Model:HEM-7322T-E
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

While the technology used in the Omron M7 Intelli IT (HEM-7322T-E), 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 failed clinical validation.
Stride BPSelf-measurement for adults and pregnancy (Preferred)Equivalence claim without published evidence