Digital Automatic Wrist Blood Pressure Monitor MD4300

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 Md4300.

Pre-market Notification Details

Device IDK171379
510k NumberK171379
Device Name:Digital Automatic Wrist Blood Pressure Monitor MD4300
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 Received2017-05-11
Decision Date2018-04-10
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.