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Nihon-Kohden ZM-940PG

Device Model:ZM-940PG
Manufacturer:

Distributer: Nihon Kohden UK Ltd., Unit 118 Trident Court, 1 Oakcroft Road Chessington, Surrey KT9 1BD, UNITED KINGDOM.

Sole: Nihon Kohden Corporation, 1-31-4 Nishiochiai, Shinjuku-ku, Tokyo 161-8560, JAPAN.

Measuring functions:Blood pressure, SpO2, ECG, Respiration
Primary Client Use:Intended for ambulatory patient monitoring
Measurement Site:Finger
Measurement Occurrence:Continuous measurement
Availability:Available Currently
Assessment:

While the technology used in the Nihon-Kohden ZM-940PG, to measure blood pressure, has been claimed as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device has not shown to have been clinically validated.
Japanese Society of HypertensionProfessional use (2016, 2018-2019)Implied equivalence to the Nihon-Kohden Vismo PVM-2701