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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 K193456
Device Name Arm Blood Pressure Monitor
Applicant
Ningbo Ranor Medical Science & Technology Co., Ltd.
# 127 Fenghui Rd., Wangchun Industrial Park,
Haishu District
Ningbo,  CN 315000
Applicant Contact Emma Hu
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.608,# 738,Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/13/2019
Decision Date 07/16/2020
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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