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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 K143734
Device Name Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810
Applicant
Grandway Technology (Shenzhen) Limited
Block 6 And 7, Zhu Keng Industrial Zone, Ping Shan
Long Gang District
Shenzhen, Guang Dong,  CN 518118
Applicant Contact Patrick Chow
Correspondent
Grandway Technology (Shenzhen) Limited
Block 6 And 7, Zhu Keng Industrial Zone, Ping Shan
Long Gang District
Shenzhen, Guang Dong,  CN 518118
Correspondent Contact Patrick Chow
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/30/2014
Decision Date 05/02/2015
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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