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Fukuda Denshi DS-7000

Device Name:Dynascope
Device Model:DS-7000
Manufacturer:Sole: Fukuda Denshi Co. Ltd., 2-23-5 Kita Ueno, Taito-Ku, Tokyo 110-0014, JAPAN.
Measuring functions:Blood pressure, Arrhythmias, SpO2, Temperature, ECG, Respiration
Primary Client Use:Intended for patient monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Intermittent measurements at specified intervals or times
Availability:Available Currently

The technology used in the Fukuda Denshi DS-7000, to measure blood pressure, has passed in clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval RecommendationOlder clinical validation; older protocol; multiple clinical validations
ESH (Europe)Professional use for childrenPublished evidence
Japanese Society of HypertensionProfessional use (2016, 2018)Published evidence
AMA VDL CriteriaSatisfies stated criteria510(k) K083697, K081891 plus

Validation Publications

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)