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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K231961
Device Name NIBPCuff
Applicant
Shenzhen SINO-K Medical Technology Co.,Ltd
Room401,Bldg2,Veteran Ind.city,Gonglc Community
xixiang Strcct,Baoan District
Shenzhen,  CN 518115
Applicant Contact Lao Chengxin
Correspondent
Shenzhen Choncorut Medical Consulting Co., Ltd.
Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Yang Jie
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received07/03/2023
Decision Date 08/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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