HL888

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.

Pre-market Notification Details

Device IDK023834
510k NumberK023834
Device Name:HL888
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant HEALTH & LIFE CO., LTD. 6F,NO.407, CHUNG SHAN RD. SEC.02, CHUNG HO CITY Taipei Hsien,  TW 235
ContactSusan Chen
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2002-11-18
Decision Date2003-01-14

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