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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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