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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 K171889
Device Name Reusable Blood Pressure Cuff
Applicant
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
You Yi Industrial Park, Songlin Town, Wujiang
Suzhou,  CN 215222
Applicant Contact Yang Qidong
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received06/26/2017
Decision Date 12/19/2017
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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