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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 K143735
Device Name Digital Automatic Blood Pressure Monitor MD2300
Applicant
Grandway Technology (Shenzhen) Limited
Block 6 and 7, Zhu Keng Industrial Zone,
Ping Shan, Long Gang District,
Shenzhen,  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,  CN 518118
Correspondent Contact Patrick Chow
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/30/2014
Decision Date 07/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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