FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031

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, Models: Kd-5917, Kd-5915, Kd-5031.

Pre-market Notification Details

Device IDK091737
510k NumberK091737
Device Name:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant ANDON HEALTH CO.,LTD NO 31, CHANGJIANG ROAD NANKAI DISTRICT Tianjin,  CN 300193
ContactLiu Yi
CorrespondentLiu Yi
ANDON HEALTH CO.,LTD NO 31, CHANGJIANG ROAD NANKAI DISTRICT Tianjin,  CN 300193
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-11
Decision Date2009-08-18
Summary:summary

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