T:slim X2 Insulin Pump With Interoperable Technology

Tandem Diabetes Care, Inc.

The following data is part of a De Novo classification by Tandem Diabetes Care, Inc. with the FDA for T:slim X2 Insulin Pump With Interoperable Technology.

Pre-market Notification Details

DeNovo IDDEN180058
Device Name:T:slim X2 Insulin Pump With Interoperable Technology
Applicant Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego,  CA  92121
ContactMichael Sarrasin
Product CodeQFG
DecisionGranted (DENG)
Review Advisory BoardClinical Chemistry
TypeDirect
Date Received2018-10-29
Decision Date2019-02-14
Reclassification Order:Reclassification Order

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