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 IDK180240
510k NumberK180240
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
ContactJ. S. Hsu
CorrespondentJ. S. Hsu
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 Received2018-01-29
Decision Date2018-10-17
Summary:summary

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