CareSens S Clear BT 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 S Clear Bt Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK192859
510k NumberK192859
Device Name:CareSens S Clear BT Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu Seoul,  KR 06646
ContactJoon Ho Jung
CorrespondentJoon Ho Jung
i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu Seoul,  KR 06646
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
510k Review PanelClinical Chemistry
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-04
Decision Date2020-01-24

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.