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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K230642
Device Name Electronic Blood Pressure Monitor
Applicant
Dongguan Kangweile Electronic Technology Co., Ltd.
4th Floor, Bldg. D, Yizhong Science Park, 83 Jinsha 2nd
Rd., Shuikou Villiage, Dalang Town
Dongguan,  CN 523770
Applicant Contact Zhixin Gao
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.Ltd
Rm. 1470, Jingting Bldg., Dongzhou Communnity, Guangming
St., Guangming District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/08/2023
Decision Date 08/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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