DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0

System, Measurement, Blood-pressure, Non-invasive

GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

The following data is part of a premarket notification filed by Grandway Technology (shenzhen) Limited with the FDA for Digital Automatic Blood Pressure Monitor Bpm03 Series Model Md03x0.

Pre-market Notification Details

Device IDK123073
510k NumberK123073
Device Name:DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Building 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District Shenzhen,  CN 518118
ContactPatrick Chow
CorrespondentPatrick Chow
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Building 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District Shenzhen,  CN 518118
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-01
Decision Date2013-03-11
Summary:summary

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