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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 K903133
Device Name OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C
Applicant
OMRON MARSHALL PRODUCTS, INC.
600 BARCLAY BLVD.
LINCOLNSHIRE,  IL  60069
Applicant Contact CASEY GUZNICZAK
Correspondent
OMRON MARSHALL PRODUCTS, INC.
600 BARCLAY BLVD.
LINCOLNSHIRE,  IL  60069
Correspondent Contact CASEY GUZNICZAK
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/17/1990
Decision Date 01/18/1991
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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