T:slim X2 Insulin Pump With Interoperable Technology

Alternate Controller Enabled Insulin Infusion Pump

Tandem Diabetes Care, Inc.

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

Pre-market Notification Details

Device IDK201214
510k NumberK201214
Device Name:T:slim X2 Insulin Pump With Interoperable Technology
ClassificationAlternate Controller Enabled Insulin Infusion Pump
Applicant Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego,  CA  92121
ContactAshley Reynolds
CorrespondentAshley Reynolds
Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego,  CA  92121
Product CodeQFG  
CFR Regulation Number880.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-05
Decision Date2020-06-04

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