Fukuda Denshi FM-970
There appears to be no peer-reviewed clinical validation information available on the technology used in the Fukuda Denshi FM-970 to measure blood pressure.
|Medaval||Not recommended||This device has not been clinically validated.|
|Japanese Society of Hypertension||Professional use (2019)||Published evidence|
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.
Fukuda Denshi FM-800
Nakamura K, Kikuya M, Hara A, Hirose T, Obara T, Metoki H, Asayama K, Inoue R, Ohkubo T, Totsune K, Imai Y. Validation of the FM-800 ambulatory blood pressure monitor according to the Association for the Advancement of Medical Instrumentation criteria and the International Protocol. Clin Exp Hypertens. 2010;32(8):523-7. doi: 10.3109/10641963.2010.496513. PMID: 21091358.
ESH-IP:2002 - Pass General population
SP10:1996 - Pass General population