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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 K152468
Device Name Reusable Blood Pressure Cuff
Applicant
Shenzhen Vistar Medical Supplies Co., Ltd.
808, Hanhaida Bldg., # 7 Songgang Blvd.
Songgang Town
Shenzhen,  CN 518105
Applicant Contact Zhenxun Chen
Correspondent
Beijing Believe Tech.Service Co., Ltd.
1-202, Build 3, Beijing New World, #5 Chaoyang Rd.
Chaoyang District
Beijing,  CN 100024
Correspondent Contact Ray Wang
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received08/31/2015
Decision Date 10/29/2015
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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