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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 K261136
Device Name Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)
Applicant
Guangzhou Daxin Health Technology Co., Ltd.
Rm. 510, Bldg. A02,Guangzhou Knowledge City International Le
Rm. 601, Bldg. 3, # 9, Jinshagang Rd. 1, Dalang Town, Donggu
Guangzhou,  CN 510700
Applicant Contact Yanjuan(Jane) Zhu
Correspondent
Guangzhou Daxin Health Technology Co., Ltd.
Rm. 510, Bldg. A02,Guangzhou Knowledge City International Le
Rm. 601, Bldg. 3, # 9, Jinshagang Rd. 1, Dalang Town, Donggu
Guangzhou,  CN 510700
Correspondent Contact Yanjuan(Jane) Zhu
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/07/2026
Decision Date 07/23/2026
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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