Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810

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 Bpm28 Series - Md2800, Md2810.

Pre-market Notification Details

Device IDK143734
510k NumberK143734
Device Name:Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Block 6 And 7, Zhu Keng Industrial Zone, Ping Shan Long Gang District Shenzhen, Guang Dong,  CN 518118
ContactPatrick Chow
CorrespondentPatrick Chow
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Block 6 And 7, Zhu Keng Industrial Zone, Ping Shan Long Gang District Shenzhen, Guang Dong,  CN 518118
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-30
Decision Date2015-05-02
Summary:summary

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