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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 K142088
Device Name DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES
Applicant
Grandway Technology (Shenzhen) Limited
Block 6 And 7, Zhu Keng Industrial Zone, Ping Shan,
Long Gang District, Shenzhen,
Guang Dong,  CN
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
Correspondent Contact PATRICK CHOW
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/01/2014
Decision Date 10/31/2014
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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