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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 K211747
Device Name Reusable NIBP Cuff
Applicant
Shenzhen Coreray Technology Co., Ltd.
Floor 5, Bldg. 10, Huangbeiling Jingxuan Industrial Park
Yousong Community, Longhua District
Shenzhen,  CN 518109
Applicant Contact Simon Fan
Correspondent
Shenzhen Coreray Technology Co., Ltd.
Floor 5, Bldg. 10, Huangbeiling Jingxuan Industrial Park
Yousong Community, Longhua District
Shenzhen,  CN 518109
Correspondent Contact Simon Fan
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received06/07/2021
Decision Date 09/23/2021
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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