FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA

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, Models Hl888ea, Hl888cf, Hl888gf And Hl888qa.

Pre-market Notification Details

Device IDK042853
510k NumberK042853
Device Name:FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA
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 Received2004-10-15
Decision Date2004-11-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14719872489044 K042853 000
04719872483144 K042853 000

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