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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 K021239
Device Name EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M
Applicant
Eikon Healthcare Device Corp.
No 58, Fu-Chiun St.
Hsin-Chu City,,  TW
Applicant Contact JEN KE-MIN
Correspondent
Eikon Healthcare Device Corp.
No 58, Fu-Chiun St.
Hsin-Chu City,,  TW
Correspondent Contact JEN KE-MIN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/18/2002
Decision Date 11/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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