EASYMAX Tag Self-Monitoring Blood Glucose System

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 Tag Self-monitoring Blood Glucose System.

Pre-market Notification Details

Device IDK201258
510k NumberK201258
Device Name:EASYMAX Tag Self-Monitoring Blood Glucose System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant EPS Bio Technology Corp. No. 8 R&D RD.III Hsinchu Science Park Hsinchu City,  TW 30077
ContactIden Chen
CorrespondentSteve Tseng
EPS Bio Technology Corp. No. 8 R&D RD.III, Hsinchu Science Park Hsinchu,  TW 30077
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-11
Decision Date2021-09-01

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