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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 K211532
Device Name Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33
Applicant
Yibin Junxin Electronics Technology Co., Ltd.
Bldg. B2, # 136, W. Section Of Xinggang Rd.,
Lingang Economic And Technological Devel
Yibin,  CN 644000
Applicant Contact Guan Chaoze
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd.,
Huangpu District
Guangzhou,  CN 510700
Correspondent Contact Cassie Lee
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/18/2021
Decision Date 01/19/2022
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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