Globalcare Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Globalcare Medical Technology Co., Ltd

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

Pre-market Notification Details

Device IDK192609
510k NumberK192609
Device Name:Globalcare Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Globalcare Medical Technology Co., Ltd No.7 Factory, European Industrial Park, No. 39 Mid Industrial Main Road Xiaolan Town, Zhongshan City,  CN 528415
ContactJanice Deng
CorrespondentRoger Gray
Donawa Lifescience Consulting Srl Piazza Albania 10 Rome,  IT 00153
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-20
Decision Date2020-04-21

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