Digital Automatic Wrist Blood Pressure Monitor SWBPM22 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 Swbpm22 Series.

Pre-market Notification Details

Device IDK163113
510k NumberK163113
Device Name:Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-07
Decision Date2017-01-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04895045403628 K163113 000

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