Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)

System, Measurement, Blood-pressure, Non-invasive

Jiangxi AICARE Medical Technology Co., Ltd

The following data is part of a premarket notification filed by Jiangxi Aicare Medical Technology Co., Ltd with the FDA for Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,x8, X11).

Pre-market Notification Details

Device IDK221040
510k NumberK221040
Device Name:Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Jiangxi AICARE Medical Technology Co., Ltd No.6, South Side Of Nanhuan Road Qianping Industrial Park, Le'an Country Fuzhou,  CN 344300
ContactLizhu Xiao
CorrespondentBing Huang
Feiying Drug And Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen,  CN 518052
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-07
Decision Date2022-08-31

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