Fukuda Denshi FM-800
Description: The Fukuda Denshi FM-800 is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for ambulatory blood pressure monitoring.
Assessment:
The technology used in the Fukuda Denshi FM-800, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | Legacy approval | Older clinical validation; older protocol | ||
| ESH (Europe) | ABPM | Published evidence | ||
| Japanese Society of Hypertension | Professional use (2016, 2018-2020) | Published evidence | ||
Device Family:Fukuda Denshi FM-800J, Fukuda Denshi FM-970J (J JHS Implied Equivalence)
Validation Publications
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
