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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 K021682
Device Name OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC
Applicant
OMRON HEALTHCARE, INC.
300 LAKEVIEW PKWY.
VERNON HILLS,  IL  60061
Applicant Contact IWAO KOJIMA
Correspondent
OMRON HEALTHCARE, INC.
300 LAKEVIEW PKWY.
VERNON HILLS,  IL  60061
Correspondent Contact IWAO KOJIMA
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/22/2002
Decision Date 12/12/2002
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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