Wireless Smart Gluco-Monitoring System

System, Test, Blood Glucose, Over The Counter

Andon Health Co., Ltd

The following data is part of a premarket notification filed by Andon Health Co., Ltd with the FDA for Wireless Smart Gluco-monitoring System.

Pre-market Notification Details

Device IDK153278
510k NumberK153278
Device Name:Wireless Smart Gluco-Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Andon Health Co., Ltd No. 3 Jinping Street, Ya'an Road, Nankai District Tianjin, P.R. China Tianjin,  CN 300190
ContactYi Liu
CorrespondentYi Liu
Andon Health Co., Ltd No. 3 Jinping Street, Ya'an Road, Nankai District Tianjin, P.R. China Tianjin,  CN 300190
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-12
Decision Date2016-08-19
Summary:summary

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