Digital Automatic Blood Pressure Monitor MD3600

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 Md3600.

Pre-market Notification Details

Device IDK163679
510k NumberK163679
Device Name:Digital Automatic Blood Pressure Monitor MD3600
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Block 7, Zhu Keng Industrial Zone, Ping Shan District Shenzhen,  CN 518118
ContactPatrick Chow
CorrespondentPatrick Chow
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Block 7, Zhu Keng Industrial Zone, Ping Shan District Shenzhen,  CN 518118
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-27
Decision Date2017-06-07
Summary:summary

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