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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 K162092
Device Name Evolv Model BP7000 Upper Arm Blood Pressure Monitor
Applicant
Omron Healthcare, Inc.
1925 W. Field Ct.
Lake Forest,  IL  60045
Applicant Contact RENEE THORNBOROUGH
Correspondent
Experien Group
755 N Mathilda Ave.
Suite 100
Sunnyvale,  CA  94085
Correspondent Contact RONALD S. WARREN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/28/2016
Decision Date 11/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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