Wrist 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 Wrist Electronic Sphygmomanometer.

Pre-market Notification Details

Device IDK193386
510k NumberK193386
Device Name:Wrist Electronic Sphygmomanometer
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Shenzhen Changkun Technology Co., Ltd. 801, 3 Floor, 4 Floor, 5 Floor, 6 Floor, 7 Floor 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)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-06
Decision Date2021-01-27

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