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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 K250185
Device Name Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)
Applicant
Jiangxi Aicare Medical Technology Co., Ltd.
#6, S. Side Of Nanhuan Rd. Qianping Industrial Park
Le'An County
Fuzhou City,  CN 344300
Applicant Contact Xiao Lizhu
Correspondent
Jiangxi Aicare Medical Technology Co., Ltd.
#6, S. Side Of Nanhuan Rd. Qianping Industrial Park
Le'An County
Fuzhou City,  CN 344300
Correspondent Contact Xiao Lizhu
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/22/2025
Decision Date 07/14/2025
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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