FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904

System, Measurement, Blood-pressure, Non-invasive

ANDON HEALTH CO.,LTD

The following data is part of a premarket notification filed by Andon Health Co.,ltd with the FDA for Fully Automatic Electronic Blood Pressure Monitor, Model Kd-5904.

Pre-market Notification Details

Device IDK083318
510k NumberK083318
Device Name:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant ANDON HEALTH CO.,LTD NO 31, CHANGJIANG ROAD NANKAI DISTRICT Tianjin,  CN 300190
ContactLiu Yi
CorrespondentLiu Yi
ANDON HEALTH CO.,LTD NO 31, CHANGJIANG ROAD NANKAI DISTRICT Tianjin,  CN 300190
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-10
Decision Date2009-01-29
Summary:summary

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