Livongo Blood Glucose Monitoring System (BG1000)

System, Test, Blood Glucose, Over The Counter

Livongo Health, Inc.

The following data is part of a premarket notification filed by Livongo Health, Inc. with the FDA for Livongo Blood Glucose Monitoring System (bg1000).

Pre-market Notification Details

Device IDK200277
510k NumberK200277
Device Name:Livongo Blood Glucose Monitoring System (BG1000)
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Livongo Health, Inc. 150 W. Evelyn Ave, Suite 150 Mountain View,  CA  94041
ContactJacob Gendler
CorrespondentJacob Gendler
Livongo Health, Inc. 150 W. Evelyn Ave, Suite 150 Mountain View,  CA  94041
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-04
Decision Date2020-06-04

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