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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 K253152
Device Name BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
Applicant
Biozen, LLC
7023 N Classen Blvd.
Oklahoma City,  OK  73116
Applicant Contact Omer Inan
Correspondent
Biozen, LLC
7023 N Classen Blvd.
Oklahoma City,  OK  73116
Correspondent Contact Omer Inan
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/26/2025
Decision Date 05/06/2026
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		 Yes
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