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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 K193629
Device Name Disposable NIBP Cuff
Applicant
Shenzhen Changke Connect Electronics Co., Ltd.
A2-4th Floor Of Xiang Dali Technology Park
#87 Of Hengping Rd., Henggang
Shenzhen,  CN 518000
Applicant Contact Yahui Zhou
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
# A415, Block A, Nanshan Medical Devices Industrial Park
Nanshan District,
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received12/26/2019
Decision Date 03/25/2020
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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