Glooko Mobile Insulin Dosing System

Calculator, Drug Dose

Glooko, Inc

The following data is part of a premarket notification filed by Glooko, Inc with the FDA for Glooko Mobile Insulin Dosing System.

Pre-market Notification Details

Device IDK171450
510k NumberK171450
Device Name:Glooko Mobile Insulin Dosing System
ClassificationCalculator, Drug Dose
Applicant Glooko, Inc 899 West Evelyn Avenue Mountain View,  CA  94041
ContactTejasvi Pasi
CorrespondentTejasvi Pasi
Glooko, Inc 899 West Evelyn Avenue Mountain View,  CA  94041
Product CodeNDC  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-17
Decision Date2018-02-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00855093008019 K171450 000
00855093008002 K171450 000

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