Basal-IQ Technology

Interoperable Automated Glycemic Controller, Insulin Suspend

Tandem Diabetes Care, Inc.

The following data is part of a premarket notification filed by Tandem Diabetes Care, Inc. with the FDA for Basal-iq Technology.

Pre-market Notification Details

Device IDK193483
510k NumberK193483
Device Name:Basal-IQ Technology
ClassificationInteroperable Automated Glycemic Controller, Insulin Suspend
Applicant Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego,  CA  92121
ContactTrevor J Dendo
CorrespondentTrevor J Denbo
Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego,  CA  92121
Product CodeQJS  
CFR Regulation Number862.1356 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
510k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-17
Decision Date2020-02-28

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