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510(k) Data Aggregation
K Number
K162230Device Name
Fully Automatic Electronic Blood Pressure Monitor
Manufacturer
ADON HEALTH CO., LTD.
Date Cleared
2016-11-18
(102 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ADON HEALTH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KD-5920, KD-5920L and KD-5923 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.
Device Description
KD-5920, KD-5920L and KD-5923 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.
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