Electronic Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd

The following data is part of a premarket notification filed by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd with the FDA for Electronic Blood Pressure Monitor.

Pre-market Notification Details

Device IDK200939
510k NumberK200939
Device Name:Electronic Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Yunyang Industrial Park Danyang,  CN 212300
ContactRui Li
CorrespondentGiselle Zhang
Emergo Global Consulting , LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-08
Decision Date2020-08-20

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