Digital Automatic Wrist Blood Pressure Monitor MD2400

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 Wrist Blood Pressure Monitor Md2400.

Pre-market Notification Details

Device IDK143733
510k NumberK143733
Device Name:Digital Automatic Wrist Blood Pressure Monitor MD2400
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,  CN 518118
ContactPatrick Chow
CorrespondentPatrick Chow
Grandway Technology (Shenzhen) Limited Block 6 And 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 Received2014-12-30
Decision Date2015-04-03
Summary:summary

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