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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 K253982
Device Name Korotkoff sound blood pressure monitor
Applicant
Beijing Hanvon Health Technology Co., Ltd.
Rm. 162, 1st Floor And Rm. 256, 2nd Floor,
Hanwang Bldg. 5, #8 Dongbeiwangxi Rd.,Haidian District
Beijing,  CN 100193
Applicant Contact Qingjun Yi
Correspondent
Beijing Hanvon Health Technology Co., Ltd.
Rm. 162, 1st Floor And Rm. 256, 2nd Floor,
Hanwang Bldg. 5, #8 Dongbeiwangxi Rd.,Haidian District
Beijing,  CN 100193
Correspondent Contact Qingjun Yi
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/12/2025
Decision Date 04/21/2026
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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