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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 K140583
Device Name DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES
Applicant
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
ZHU KENG INDUSTRIAL ZONE
PING SHAN, LONG GANG DISTRICT
SHENSHEN, GUANG DONG,  CN 518118
Applicant Contact PATRICK CHOW
Correspondent
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
ZHU KENG INDUSTRIAL ZONE
PING SHAN, LONG GANG DISTRICT
SHENSHEN, GUANG DONG,  CN 518118
Correspondent Contact PATRICK CHOW
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/06/2014
Decision Date 06/18/2014
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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