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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 K173197
Device Name Reusable NIBP Cuff
Applicant
Orantech, Inc.
Zone#A, 4f, 1st Bld, 7th Industrial Zone
Yulv Community, Gongming
Shenzhen,  CN 518106
Applicant Contact Yunxi Xiong
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
22a, Haijing Sq., # 18, Taizi Rd.
Nanshan District, Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received10/02/2017
Decision Date 08/21/2018
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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