Automatic Digital Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

AVICHE Shandong Medical Technology Co, Ltd.

The following data is part of a premarket notification filed by Aviche Shandong Medical Technology Co, Ltd. with the FDA for Automatic Digital Blood Pressure Monitor.

Pre-market Notification Details

Device IDK210152
510k NumberK210152
Device Name:Automatic Digital Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant AVICHE Shandong Medical Technology Co, Ltd. Floor 26, Building A, A2-1 Jinan Pharm Valley Gangxingsan Road, High-tech District Jinan,  CN
ContactZhike Song
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 Received2021-01-21
Decision Date2021-09-23

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