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Omron BP7900 (HEM-7530T-Z)
Device Name:
Device Model:
Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:
Blood pressure, ECG
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Available Currently
Availability according to Countries or Regions:
United States
The Omron BP7900 (HEM-7530T-Z) is a dual monitor for blood pressure and ecg. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
The technology used in the Omron BP7900 (HEM-7530T-Z), to measure blood pressure, has been declared as being substantially equivalent to that used in another device, according to 510(k), but this is not compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP AMA VDL (US) Self-measurement Implied equivalence to the Omron HEM-7311 plus 510(k) K182579
BP FDA (US) 510(k) 510(k) K182579
Device Family:
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 HEM-9210T (HEM-9210T-E)

Alpert BS. Validation of the Omron HEM-9210T by the ANSI/AAMI/ISO 81060-2:2013 with two novel cuffs: wide-range and extra-large. Blood Press Monit. 2017 Jun;22(3):166-8. Epub: 2017 Mar 1. doi: 10.1097/MBP.0000000000000250. PMID: 28252519.

81060-2:2013 - Pass General population

Van Den Heuvel JFM, Lely AT, Franx A, Bekker MN. Validation of the iHealth Track and Omron HEM-9210T automated blood pressure devices for use in pregnancy. Pregnancy Hypertens. 2019 Jan;15:37-41. Epub: 2018 Nov 2. doi: 10.1016/j.preghy.2018.10.008. PMID: 30825925.

ESH-IP:2010 - Pass Pregnancy (n=33), Pre-eclampsia (n=10)

Takahashi H. Validation of Home Blood Pressure-monitoring Devices Omron EVOLV (HEM-7600T-E), HEM-9210T, and M3 Comfort (HEM-7134-E) According to European Society of Hypertension International Protocol (ESH-IP) Revision 2010. J Clin Physiol (Jpn). 2019 Feb 1;49(1):37-46. doi: 10.34363/jocp.49.1_37. Available from: www.jstage.jst.go.jp.

ESH-IP:2010 - Pass General population