Certificate of Equivalence
HDV-TDH-240027
Herewith we, OMRON HEALTHCARE Co., Ltd. certify the blood pressure monitors below are substantially equivalent to HEM-9200T which is clinically validated* employs the same algorithm and the same components as the predicate device for determining blood pressure.
| Current monitors | Validated predicate monitor | Clinical paper info. |
|---|---|---|
| HEM-7142T1-AP Standard cuff: HEM-CR24 |
HEM-9200T | *Hakuo Takahashi, Kanako Saito and Nobuki Yakura. Validation of Omron HEM-9200T, a home blood pressure monitoring device for the upper arm, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 protocol. Journal of Human Hypertension 09 April 2021 |
Note: The validation study for HEM-9200T is carried out with 3 cuffs; HEM-CS24(17-22cm), HEM-CR24(22-32cm), and HEM-RML31(22-42cm). According to the sales strategy, either CR24 or RML31 is bundled with the main unit and either an assortment of CS24/CR24/RML31 or CS24/RML31 or CR24/RML31 is set as optional accessory.
Very Truly Yours,
Dec. 21, 2024
Takehiro Hamaguchi
Product Development HQ
General Manager
