Omron HEM-6323T
Device Model:
HEM-6323T
Manufacturer:
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:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Japan
Device Manual:
Description:
The Omron HEM-6323T is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the Omron HEM-6323T, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | Japanese Society of Hypertension | Self-measurement (Previous: 2018) | Implied equivalence to the Omron RS3 (HEM-6130-E), RS6 (HEM-6221-E) or RS8 (HEM-6310F-E) |
Device Family:
Omron RS8 (HEM-6310F-E)J, Omron HEM-6301J, Omron HEM-6321TJ, Omron HEM-6323TJ, Omron HEM-6324TJ, Omron HEM-6300FJ, Omron HEM-6310FJ, Omron HEM-6311J, Omron HEM-6320TJ
Legend: J JHS Implied Equivalence
Legend: J JHS Implied 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 RS8 (HEM-6310F-E)
Takahashi H, Yoshika M, Yokoi T. Validation of Omron RS8, RS6, and RS3 home blood pressure monitoring devices, in accordance with the European Society of Hypertension International Protocol revision 2010. Vasc Health Risk Manag. 2013;9:265-72. Epub: 2013 May 28. doi: 10.2147/VHRM.S44569. PMID: 23745050.
ESH-IP:2010 - Pass General population