Fukuda Denshi DS-8500
The technology used in the Fukuda Denshi DS-8500, 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.
Accuracy Assessment | Recommendation | Basis | ||
---|---|---|---|---|
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
Alpert BS, Blakely DW. Validation of the Fukuda Denshi DS-7000 patient monitor by AAMI standard testing. Blood Press Monit. 2009 Dec;14(6):274-6. doi: 10.1097/MBP.0b013e328332fd6d. PMID: 19923985.
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)