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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 K261929
Device Name Upper Arm Blood pressure monitor (BP7155D)
Applicant
OMRON Healthcare, Inc.
2895 Greenspoint Pkwy.
Suite 100
Hoffman Estates,  IL  60169
Applicant Contact Bhoomika Joyappa
Correspondent
OMRON Healthcare, Inc.
2895 Greenspoint Pkwy.
Suite 100
Hoffman Estates,  IL  60169
Correspondent Contact Bhoomika Joyappa
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/09/2026
Decision Date 09/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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