DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES

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 Wbpm15 Series.

Pre-market Notification Details

Device IDK120673
510k NumberK120673
Device Name:DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES
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 Received2012-03-05
Decision Date2013-02-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04895045403604 K120673 000

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