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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K181154
Device Name Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
Applicant
Shenzhen Med-Link Electronics Tech Co., Ltd.
4th Floor, Bldg. A, Yingtailong Industrial Prk,
Dalang S. Rd., Longhua District
Shenzhen,  CN 518109
Applicant Contact Baihan Feng
Correspondent
Shenzhen Med-Link Electronics Tech Co., Ltd.
4th Floor, Bldg. A, Yingtailong Industrial Prk,
Dalang S. Rd., Longhua District
Shenzhen,  CN 518109
Correspondent Contact Baihan Feng
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/01/2018
Decision Date 08/02/2019
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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