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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 K012796
Device Name AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000
Applicant
Amluck, Inc.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Applicant Contact YANG TIEN-HSING
Correspondent
Amluck, Inc.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Correspondent Contact YANG TIEN-HSING
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/21/2001
Decision Date 03/14/2002
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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