DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 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 Wbpm10 Series.

Pre-market Notification Details

Device IDK110299
510k NumberK110299
Device Name:DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED ZHU KENG INDUSTRIAL ZONE PING SHAN, LONG GANG DISTRICT Shenshen, Guang Dong,  CN 518118
ContactPatrick Chow
CorrespondentPatrick Chow
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED ZHU KENG INDUSTRIAL ZONE PING SHAN, LONG GANG DISTRICT Shenshen, Guang Dong,  CN 518118
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-01
Decision Date2011-03-21
Summary:summary

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