CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER

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 Caresens N Voice Multi Blood Glucose Monitoring System, Caresens N Voice Multi Blood Glucose Meter.

Pre-market Notification Details

Device IDK132288
510k NumberK132288
Device Name:CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant i-SENS, Inc. 27-36 GWANGUN-RO, NOWON-GU Seoul,  KR 139-845
ContactChae Yun Lim
CorrespondentChae Yun Lim
i-SENS, Inc. 27-36 GWANGUN-RO, NOWON-GU Seoul,  KR 139-845
Product CodeNBW  
Subsequent Product CodeCGA
Subsequent Product CodeJJX
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-23
Decision Date2013-11-22
Summary:summary

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