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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 K251102
Device Name Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603)
Applicant
Cemho Medical Technology (Guangdong) Co., Ltd.
Cemho Medical Industrial Park, W. Of Xinghe Line,
Dongguan Shijie (Xingning) Industrial Transfer Industrial Pk
Meizhou City,  CN 514500
Applicant Contact Gang Hong
Correspondent
Qimmiq Medical Consulting Service Co., Ltd.
Rm.406, Bldg. C, Run Science Park
#18 Shenzhou Rd., Huangpu
Guangzhou,  CN 510663
Correspondent Contact Yijie You
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/11/2025
Decision Date 07/16/2025
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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