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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 K253570
Device Name Blood Pressure Monitor (W06LT)
Applicant
Shenzhen Jamr Technology Co., Ltd.
A101-301, D101-201, Jamr Science & Technology Park # 2
Guiyuan Rd. Guixiang Community Guanlan St., Longhua District
Shenzhen,  CN 518100
Applicant Contact Zhuni Chen
Correspondent
Shenzhen Jamr Technology Co., Ltd.
A101-301, D101-201, Jamr Science & Technology Park # 2
Guiyuan Rd. Guixiang Community Guanlan St., Longhua District
Shenzhen,  CN 518100
Correspondent Contact Zhuni Chen
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DXQ  
Date Received11/17/2025
Decision Date 05/20/2026
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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