Arm Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Ningbo Ranor Medical Science & Technology Co., Ltd.

The following data is part of a premarket notification filed by Ningbo Ranor Medical Science & Technology Co., Ltd. with the FDA for Arm Blood Pressure Monitor.

Pre-market Notification Details

Device IDK193456
510k NumberK193456
Device Name:Arm Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Ningbo Ranor Medical Science & Technology Co., Ltd. No. 127 Fenghui Road, Wangchun Industrial Park, Haishu District Ningbo,  CN 315000
ContactEmma Hu
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-13
Decision Date2020-07-16

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