FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)

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 Hl168kf).

Pre-market Notification Details

Device IDK113239
510k NumberK113239
Device Name:FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Zhonghe District, New Taipei,  TW 23553
ContactSarah Su
CorrespondentSarah Su
HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Zhonghe District, New Taipei,  TW 23553
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-02
Decision Date2012-03-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850842006063 K113239 000
00850842006056 K113239 000

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