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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 K231984
Device Name Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)
Applicant
Shenzhen Hingmed Medical Instrument Co., Ltd.
4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen
Road, Baoan District
Shenzhen,  CN 518102
Applicant Contact Huang YongBan
Correspondent
Shenzhen Hingmed Medical Instrument Co., Ltd.
4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen
Road, Baoan District
Shenzhen,  CN 518102
Correspondent Contact Huang YongBan
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/05/2023
Decision Date 03/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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