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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 K882393
Device Name DIGITAL BLOOD PRESSURE MONITOR MODEL HEM-703CP
Applicant
Omron Electronics, Inc.
One E. Commerce Dr.
Schaumburg,  IL  60173
Applicant Contact OISHI
Correspondent
Omron Electronics, Inc.
One E. Commerce Dr.
Schaumburg,  IL  60173
Correspondent Contact OISHI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/10/1988
Decision Date 08/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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