Arm Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Xuzhou Yongkang Electronic Science Technology Co., Ltd

The following data is part of a premarket notification filed by Xuzhou Yongkang Electronic Science Technology Co., Ltd with the FDA for Arm Blood Pressure Monitor.

Pre-market Notification Details

Device IDK183491
510k NumberK183491
Device Name:Arm Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Xuzhou Yongkang Electronic Science Technology Co., Ltd 4F Building C8, 40 Jingshan Road, Economic And Technological Development Zo Xuzhou,  CN 221009
ContactKai Li
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-17
Decision Date2019-03-24

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