H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM

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 H & L (nibp) Blood Pressure Monitor, Model Hl888em.

Pre-market Notification Details

Device IDK043186
510k NumberK043186
Device Name:H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Chung Ho City, Taipei,  TW 235
ContactPaul Hung
CorrespondentPaul Hung
HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Chung Ho City, Taipei,  TW 235
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-17
Decision Date2004-12-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14719872489037 K043186 000

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