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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 K251331
Device Name Blood Pressure Monitor (B73, BE23T)
Applicant
Shenzhen Jamr Technology Co., Ltd.
A101-301, D101-201, Jamr Science & Technology Park, # 2
Guiyuan Rd., Guixiang Community,Guanlan St.,Longhua Dist
Shenzhen,  CN 518100
Applicant Contact Can Liu
Correspondent
Shenzhen Jamr Technology Co., Ltd.
A101-301, D101-201, Jamr Science & Technology Park, # 2
Guiyuan Rd., Guixiang Community,Guanlan St.,Longhua Dist
Shenzhen,  CN 518100
Correspondent Contact Can Liu
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DXQ  
Date Received04/30/2025
Decision Date 10/27/2025
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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