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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 K040528
Device Name AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T
Applicant
Ya Horng Electronic Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Applicant Contact JEN KE-MIN
Correspondent
Ya Horng Electronic Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Correspondent Contact JEN KE-MIN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/01/2004
Decision Date 04/15/2004
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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