DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 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 Blood Pressure Monitor Bpm20 Series.

Pre-market Notification Details

Device IDK140583
510k NumberK140583
Device Name:DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 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 Received2014-03-06
Decision Date2014-06-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04895045403611 K140583 000
00853455007106 K140583 000
00853455007090 K140583 000

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