GLUCOMANAGER DATA MANAGEMENT SOFTWARE

System, Test, Blood Glucose, Over The Counter

EPS BIO TECHNOLOGY CORP.

The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Glucomanager Data Management Software.

Pre-market Notification Details

Device IDK091229
510k NumberK091229
Device Name:GLUCOMANAGER DATA MANAGEMENT SOFTWARE
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant EPS BIO TECHNOLOGY CORP. 2 F,NO.49-2, LANE 2, SEC. 2, GUANG FU ROAD Hsinchu City,  TW 300
ContactY.c. Lei
CorrespondentY.c. Lei
EPS BIO TECHNOLOGY CORP. 2 F,NO.49-2, LANE 2, SEC. 2, GUANG FU ROAD Hsinchu City,  TW 300
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-27
Decision Date2009-07-31
Summary:summary

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