FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963

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-5963, Kd-7963.

Pre-market Notification Details

Device IDK093528
510k NumberK093528
Device Name:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963
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 Received2009-11-16
Decision Date2009-12-04
Summary:summary

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