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Fukuda Denshi DS-8200

Device Name:Dynascope
Device Model:DS-8200
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, CO, EtCO2, 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-8200, 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 (2016, 2018-2019)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)