BreathID Smart System

Test, Urea (breath Or Blood)

Exalenz Bioscience Ltd.

The following data is part of a premarket notification filed by Exalenz Bioscience Ltd. with the FDA for Breathid Smart System.

Pre-market Notification Details

Device IDK193610
510k NumberK193610
Device Name:BreathID Smart System
ClassificationTest, Urea (breath Or Blood)
Applicant Exalenz Bioscience Ltd. 4 Ha'Maayan St. Modiin,  IL 7177872
ContactRaffi Werner
CorrespondentRaffi Werner
Exalenz Bioscience Ltd. 4 Ha'Maayan St. Modiin,  IL 7177872
Product CodeMSQ  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
510k Review PanelMicrobiology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-26
Decision Date2020-02-06

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