Full Automatic(NIBP) Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Health & Life Co., Ltd

The following data is part of a premarket notification filed by Health & Life Co., Ltd with the FDA for Full Automatic(nibp) Blood Pressure Monitor.

Pre-market Notification Details

Device IDK200521
510k NumberK200521
Device Name:Full Automatic(NIBP) Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Health & Life Co., Ltd 9F, No. 186 Jian Yi Road, Zhonghe District, New Taipei City,  TW 23553
ContactSimon Lee
CorrespondentSimon Lee
Health & Life Co., Ltd 9F, No. 186 Jian Yi Road, Zhonghe District, New Taipei City,  TW 23553
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-02
Decision Date2020-06-12

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