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Fukuda Denshi FM-970

Device Model:FM-970
Manufacturer:Sole: Fukuda Denshi Co. Ltd., 2-23-5 Kita Ueno, Taito-Ku, Tokyo 110-0014, JAPAN.
Measuring functions:Blood pressure, SpO2, 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
Assessment:

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.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device has not been clinically validated.
Japanese Society of HypertensionProfessional use (2019)Published evidence

Device Family:Fukuda Denshi FM-800J, Fukuda Denshi FM-970J (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.

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