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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 K140762
Device Name AUTOMATIC BLOOD PRESSURE MONITOR
Applicant
Jawon Medical Co., Ltd.
1208-12 Singsang-Ri, Jinryang-Eup
Kyungsan-City, Kyungsang-Bukdo,  KR 712-830
Applicant Contact WOO PARK
Correspondent
Medmonts Co., Ltd.
Life-Officetel 320,40,63-Ro
Youngdeungpo-Gu
Seoul,  KR 150-731
Correspondent Contact WOO PARK
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/27/2014
Decision Date 07/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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