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 IDK142088
510k NumberK142088
Device Name:DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES
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, Guang Dong,  CN
ContactPatrick Chow
CorrespondentPatrick Chow
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED BLOCK 6 AND 7, ZHU KENG INDUSTRIAL ZONE, PING SHAN, LONG GANG DISTRICT, SHENZHEN, Guang Dong,  CN
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-01
Decision Date2014-10-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10845717006924 K142088 000
00845717006484 K142088 000

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