Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]

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 Bpm25 & Bpm26 Series [model No.: Md25x0/ Md26x0].

Pre-market Notification Details

Device IDK150373
510k NumberK150373
Device Name:Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]
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 Received2015-02-13
Decision Date2015-06-11
Summary:summary

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