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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 K171379
Device Name Digital Automatic Wrist Blood Pressure Monitor MD4300
Applicant
Grandway Technology (Shenzhen) Limited
Block 7, Zhu Keng Industrial Zone, Ping Shan District
Shenzhen,  CN 518118
Applicant Contact Patrick Chow
Correspondent
Grandway Technology (Shenzhen) Limited
Block 7, Zhu Keng Industrial Zone, Ping Shan District
Shenzhen,  CN 518118
Correspondent Contact Patrick Chow
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/11/2017
Decision Date 04/10/2018
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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