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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 K881269
Device Name OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-701C
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 Received03/24/1988
Decision Date 06/16/1988
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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