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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 K173869
Device Name Med-link Reusable Blood Pressure Cuff
Applicant
Shenzhen Med-Link Electronics Tech Co., Ltd.
4th Floor, Bldg. A, Ying Tailong Ind Park
Dalang S. Rd., Longhua
Shenzhen,  CN 518109
Applicant Contact Baihan Feng
Correspondent
Shenzhen Med-Link Electronics Tech Co., Ltd.
4th Floor, Bldg. A, Ying Tailong Ind Park
Dalang S. Rd., Longhua
Shenzhen,  CN 518109
Correspondent Contact Baihan Feng
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received12/20/2017
Decision Date 08/02/2018
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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