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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 K191593
Device Name Digital Automatic Blood Pressure Monitor MD36 Series
Applicant
Grandway Technology (Shenzhen) Limited
# 5, 2nd Industrial Zone, Zhukeng Community, Longtian
St., Pingshan District
Shenzhen,  CN 518118
Applicant Contact Patrick Chow
Correspondent
Grandway Technology (Shenzhen) Limited
# 5, 2nd Industrial Zone, Zhukeng Community, Longtian
St., Pingshan District
Shenzhen,  CN 518118
Correspondent Contact Patrick Chow
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/14/2019
Decision Date 07/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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