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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 W. Rd.
Xuzhou,  CN 221006
Applicant Contact LI ZHAOQIAN
Correspondent
Beijing Believe Tech.Service Co., Ltd.
1-202, Build 3, Beijing New World, #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
Predetermined Change
Control Plan Authorized		 No
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