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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 K202228
Device Name Omron Model BP7900 Blood Pressure Monitor + EKG
Applicant
Omron Healthcare, Inc.
1925 W. Field Court
Suite 100
Lake Forest,  IL  60045
Applicant Contact Renee Thornborough
Correspondent
Experien Group
224 Airport Pkwy., Suite 250
San Jose,  CA  95110
Correspondent Contact Kit Cariquitan
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DPS   DXH   QDA  
Date Received08/07/2020
Decision Date 04/01/2021
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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