EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008

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 Easymax N Self Monitoring Blood Glucose System, Model: Eps08008.

Pre-market Notification Details

Device IDK083099
510k NumberK083099
Device Name:EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
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 30071
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 30071
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-20
Decision Date2009-01-16

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