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Fukuda Denshi FM-800

Device Model:FM-800
Manufacturer:Sole: Fukuda Denshi Co. Ltd., 2-23-5 Kita Ueno, Taito-Ku, Tokyo 110-0014, JAPAN.
Measuring functions:Blood pressure, ECG
Primary Client Use:Intended for ambulatory blood pressure monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Intermittent measurements at specified intervals or times
Availability:Available Currently
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.

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 AssessmentRecommendationBasis
MedavalLegacy approvalOlder clinical validation; older protocol
ESH (Europe)ABPMPublished evidence
Japanese Society of HypertensionProfessional 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