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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 K021240
Device Name EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200
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
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