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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 K040159
Device Name APM BLOOD PRESSURE MONITOR, MODEL BP108A
Applicant
Asia Pacific Microsystems, Inc.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Applicant Contact Ke-Min Jen
Correspondent
Asia Pacific Microsystems, Inc.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Correspondent Contact Ke-Min Jen
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/23/2004
Decision Date 03/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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