KetoSens BT Blood B-Ketone Monitoring System

Nitroprusside, Ketones (urinary, Non-quant.)

I-SENS, Inc.

The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Ketosens Bt Blood B-ketone Monitoring System.

Pre-market Notification Details

Device IDK201551
510k NumberK201551
Device Name:KetoSens BT Blood B-Ketone Monitoring System
ClassificationNitroprusside, Ketones (urinary, Non-quant.)
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 CodeJIN  
CFR Regulation Number862.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-09
Decision Date2020-09-09

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