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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 K051862
Device Name PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR.
Applicant
Ya Horng Electronic Co., Ltd.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Applicant Contact JEN KEN-MIN
Correspondent
Ya Horng Electronic Co., Ltd.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Correspondent Contact JEN KEN-MIN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/08/2005
Decision Date 08/23/2005
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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