CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM

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 Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK121133
510k NumberK121133
Device Name:CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant i-SENS, Inc. 465-6 WOLGYE-DONG, NOWON-GU Seoul,  KR 139-845
ContactHyun Joon Oh
CorrespondentHyun Joon Oh
i-SENS, Inc. 465-6 WOLGYE-DONG, 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 Received2012-04-13
Decision Date2012-07-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10681131169858 K121133 000
20681131169817 K121133 000
10885325000440 K121133 000
20857513006203 K121133 000
10857513006190 K121133 000
20681131285746 K121133 000
10681131280621 K121133 000

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