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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 K241590
Device Name Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)
Applicant
Guangdong Xinyu Electronic and Technology Co., Ltd.
Number 42, Cuicheng Rd., Cuiheng New District
Zhongshan,  CN 528400
Applicant Contact Rita Long
Correspondent
Guangdong Xinyu Electronic and Technology Co., Ltd.
Number 42, Cuicheng Rd., Cuiheng New District
Zhongshan,  CN 528400
Correspondent Contact Rita Long
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/03/2024
Decision Date 02/03/2025
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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