HL888 AF

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 Hl888 Af.

Pre-market Notification Details

Device IDK032913
510k NumberK032913
Device Name:HL888 AF
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 Received2003-09-02
Decision Date2003-10-02

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