Fukuda Denshi DS-8100
The technology used in the Fukuda Denshi DS-8100, 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.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|Japanese Society of Hypertension||Professional use (2016, 2018-2019)||Implied equivalence to the Fukuda Denshi DS-7000|
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 DS-7000
BHS:1993 - Pass (A/A) In Normal Mode
BHS:1993 - Pass (A/A) In Quick Mode
SP10:2002 - Pass Adults and Children - In Normal Mode
SP10:2002 - Pass Adult and Children - In Quick Mode
SP10:2002 - Pass Infants (n=15) and Neonate (n=18)