Fukuda Denshi FM-970
Device Model:
FM-970
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 monitoring
Measurement Site:
BP: Upper Arm; SpO2: Finger
Measurement Occurrence:
BP: Intermittent measurements at specified intervals or times; SpO2: Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Japan
Description:
The Fukuda Denshi FM-970 is a triple monitor for abpm, oxygen saturation and holter ecg. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements and information regarding the accuracy of its oxygen saturation measurement technology does not appear to be available. Blood pressure measurements are taken from the upper arm and oxygen saturation measurements are taken from the finger. It is intended for ambulatory monitoring.
Assessment:
The technology used in the Fukuda Denshi FM-970, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4. There appears to be no peer-reviewed clinical validation information available on the technology used in the Fukuda Denshi FM-970 to measure peripheral oxygen saturation.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | Japanese Society of Hypertension | Professional use (Latest: 2019-2022) | Implied equivalence to the Fukuda Denshi FM-800 |
Device Family:
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