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Nissei DSK-1011

Device Model:DSK-1011
Manufacturer:Nihon Seimitsu Sokki Co. Ltd. (Nissei), 2508-13 Nakago Shibukawa, Gunma 377-0293, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Nissei DSK-1011, to measure blood pressure, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhile a clinical validation is claimed, it cannot be checked properly.
Japanese Society of HypertensionSelf-measurement (2016-2019)No evidence provided

Device Family:Nissei DSK-1011D, Nissei DSK-1011JZ, Nissei WSK-1021D, Nissei WSK-1021JZ (D DET Equivalence, Z Almost Certain)