FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

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.

Pre-market Notification Details

Device IDK102930
510k NumberK102930
Device Name:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant ANDON HEALTH CO.,LTD NO 3 JIN PING STREET YA AN RD NANKAI DISTRICT Tianjin,  CN 300190
ContactLiu Yi
CorrespondentLiu Yi
ANDON HEALTH CO.,LTD NO 3 JIN PING STREET YA AN RD NANKAI DISTRICT Tianjin,  CN 300190
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-04
Decision Date2010-11-03
Summary:summary

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