Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM

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, Model Hl858dm.

Pre-market Notification Details

Device IDK211127
510k NumberK211127
Device Name:Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Health & Life Co., Ltd 9F, No. 186, Jian Yi Road, Zhonghe District New Taipei City,  TW 23553
ContactPeggy Su
CorrespondentPeggy Su
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 Received2021-04-16
Decision Date2021-09-08

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