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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 K151290
Device Name Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff
Applicant
XUZHOU MAICUFF TECHNOLOGY CO.,LTD.
8#-2-1106, JINXIUJIAYUAN, JIANGUO WEST ROAD
XUZHOU,  CN 221006
Applicant Contact LI ZHAOQIAN
Correspondent
Beijing Believe Tech. Service Co., Ltd.
1-202, Build 3, Beijing New World, No.5 Chaoyang Rd.,
Chaoyang District
Beijing,  CN 100024
Correspondent Contact MR. RAY WANG
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received05/15/2015
Decision Date 06/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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