FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST 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 Wireless Blood Pressure Wrist Monitor.

Pre-market Notification Details

Device IDK121470
510k NumberK121470
Device Name:FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant ANDON HEALTH CO., LTD No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT Tianjin,  CN 300190
ContactLiu Yi
CorrespondentLiu Yi
ANDON HEALTH CO., LTD No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT Tianjin,  CN 300190
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-17
Decision Date2012-06-14
Summary:summary

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