Digital Automatic Blood Pressure Monitor BPM30 And BPM31 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 Bpm30 And Bpm31 Series.

Pre-market Notification Details

Device IDK152483
510k NumberK152483
Device Name:Digital Automatic Blood Pressure Monitor BPM30 And BPM31 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 Received2015-08-31
Decision Date2015-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04895045403666 K152483 000

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