HL168B

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 Hl168b.

Pre-market Notification Details

Device IDK002882
510k NumberK002882
Device Name:HL168B
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
ContactPaul Yang
CorrespondentPaul Yang
HEALTH & LIFE CO., LTD. 6F,NO.407, CHUNG SHAN RD. SEC.02, CHUNG HO CITY Taipei Hsien,  TW 235
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-15
Decision Date2000-10-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.