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Omron M6 AC (HEM-7322-E)

Device Name:M6 AC
Device Model:HEM-7322-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
Assessment:

The technology used in the Omron M6 AC (HEM-7322-E), to measure blood pressure, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Stride BPSelf-measurement for adults (Preferred)Equivalence claim without published evidence

Device Family:Omron BP765 (HEM-7311-ZSA)P, Omron M2 Basic (HEM-7121J-E)B,P, Omron M3 (HEM-7131-E)D,P, Omron M3 (HEM-7154-E)P, Omron M3 IT (HEM-7131U-E)D,P, Omron M6 AC (HEM-7322-E)D,P, Omron M6 AC ME (HEM-7322-ME)P (B BIHS Derivative, D DET Equivalence, P Stride Equivalence)
Validation Publications for Equivalent Devices

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Omron BP765 (HEM-7311-ZSA)

Takahashi H, Yoshika M, Yokoi T. Validation of two automatic devices for the self-measurement of blood pressure according to the ANSI/AAMI/ISO81060-2:2009 guidelines: the Omron BP765 (HEM-7311-ZSA) and the Omron BP760N (HEM-7320-Z). Vasc Health Risk Manag. 2015 Jan;9(11):49-53. doi: 10.2147/VHRM.S72438. PMID: 25657587.

81060-2:2009 - Pass General population