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 IDK130563
510k NumberK130563
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
ContactSarah Su
CorrespondentSarah 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 Received2013-03-04
Decision Date2013-06-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14719872483264 K130563 000
14719872483226 K130563 000

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