Home /  Fukuda Denshi DS-8005

Fukuda Denshi DS-8005

Device Model:DS-8005
Manufacturer:Sole: Fukuda Denshi Co. Ltd., 2-23-5 Kita Ueno, Taito-Ku, Tokyo 110-0014, JAPAN.
Measuring functions:Blood pressure, SpO2, Temperature, ECG, Respiration, CO2, EEG, Pulse rate
Primary Client Use:Intended for patient monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Intermittent measurements at specified intervals or times
Availability:Available Currently
Assessment:

The technology used in the Fukuda Denshi DS-8005, 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 AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Japanese Society of HypertensionProfessional use (2019)Implied equivalence to the Fukuda Denshi DS-7000

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 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)