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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 K182579
Device Name Omron Model BP7900 Blood Pressure Monitor + EKG
Applicant
Omron Healthcare, Inc.
1925 West Field Court, Suite 100
Lake Forest,  IL  60045
Applicant Contact Renee Thornborough
Correspondent
Experien Group
224 Airport Parkway, Suite 250
San Jose,  CA  95110
Correspondent Contact Ronald S. Warren
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DPS   DXH  
Date Received09/19/2018
Decision Date 03/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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