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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 K230176
Device Name Upper Arm Blood Pressure Monitor
Applicant
Shenzhen Yolanda Technology Co., Ltd.
Rm. 201,Jinfulai Bldg., #49-1,
Dabao Rd.,Dalang Area,Xinan St.,Baoan
Shenzhen,  CN 518000
Applicant Contact Xuejun Wang
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Rm. 1407, Jingting Bldg., Dongzhou Community, Guangming
St., Guangming District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/23/2023
Decision Date 06/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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