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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 K983855
Device Name FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F
Applicant
Jawon Medical Co., Ltd.
1208-12 Singsang-Li, Jinryang
Myun
Kyungsan-City, Kungsang-Bukdo,  KR
Correspondent
Tuv Product Service, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Correspondent Contact CAROLE STAMP
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/02/1998
Decision Date 11/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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