PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE

System, Test, Blood Glucose, Over The Counter

I-SENS, Inc.

The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Pc Care Blood Glucose Data Management Software.

Pre-market Notification Details

Device IDK100937
510k NumberK100937
Device Name:PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant i-SENS, Inc. 465-6 WOLGYE-DONG, NOWON-GU Seoul,  KR 139-845
ContactHyun Oh
CorrespondentHyun Oh
i-SENS, Inc. 465-6 WOLGYE-DONG, NOWON-GU Seoul,  KR 139-845
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-04-05
Decision Date2010-12-21
Summary:summary

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