Upper Arm Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Shenzhen Yolanda Technology Co., Ltd

The following data is part of a premarket notification filed by Shenzhen Yolanda Technology Co., Ltd with the FDA for Upper Arm Blood Pressure Monitor.

Pre-market Notification Details

Device IDK221212
510k NumberK221212
Device Name:Upper Arm Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Shenzhen Yolanda Technology Co., Ltd Room 201, Jinfulai Building, No.49-1, Dabao Road, Dalang Area, Xinan Street, Baoan Shenzhen,  CN 518000
ContactXuejun Wang
CorrespondentReanny Wang
Shenzhen Reanny Medical Devices Management Consulting., Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen,  CN 518000
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-27
Decision Date2022-08-26

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