Fukuda Denshi DSL-8001
While the technology used in the Fukuda Denshi DSL-8001, to measure blood pressure, has been claimed as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|Japanese Society of Hypertension||Professional use (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)