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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 K163648
Device Name Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series
Applicant
Grandway Technology (Shenzhen) Limited
Block 7, Zhu Keng Industrial Zone,
Ping Shan, Long Gang District,
Shenzhen,  CN 518118
Applicant Contact Patrick Chow
Correspondent
Grandway Technology (Shenzhen) Limited
Block 7, Zhu Keng Industrial Zone,
Ping Shan, Long Gang District,
Shenzhen,  CN 518118
Correspondent Contact Patrick Chow
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/23/2016
Decision Date 07/07/2017
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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