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KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is ,a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

It is designed and manufactured according to ANSI/AAMI SP10-manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-5917 is 60 times, the memory capability of KD-5915 is 2 X 60 times, the memory capability of KD-5031 is 3×30 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-5915 and KD-5031 also have the function of averaging the last three measurements, KD-5915 also has the voice function.

This submission pertains to the KD-5917, KD-5915, and KD-5031 Fully Automatic Electronic Blood Pressure Monitors. The primary study used to demonstrate effectiveness is the conformance to the AAMI SP10:2002 standard for sphygmomanometers.

1. Table of Acceptance Criteria and Reported Device Performance

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