Arm Electronic Sphygmomanometer

System, Measurement, Blood-pressure, Non-invasive

ShenZhen Changkun Technology CO.,LTD.

The following data is part of a premarket notification filed by Shenzhen Changkun Technology Co.,ltd. with the FDA for Arm Electronic Sphygmomanometer.

Pre-market Notification Details

Device IDK193387
510k NumberK193387
Device Name:Arm Electronic Sphygmomanometer
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant ShenZhen Changkun Technology CO.,LTD. 801, 3 Floor 4floor 5floor 6floor 7floor, B Building, NO.69, zhenbi Road Shenzhen,  CN 518118
ContactSteve Li
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou,  CN 510000
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-06
Decision Date2021-01-27

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