Fukuda Denshi FM-800
Device Model:
FM-800
Manufacturer:
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
Availability according to Countries or Regions:
Japan
Description:
The Fukuda Denshi FM-800 is a triple monitor for abpm, oxygen saturation and holter ecg. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. 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.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Legacy approval | Older clinical validation; older protocol |
| BP | ESH (Europe) | ABPM | Published evidence |
| BP | Japanese Society of Hypertension | Professional use (2016, 2018-2022) | Published evidence |
Device Family:
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