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.
| DeNovo ID | DEN180058 |
| Device Name: | T:slim X2 Insulin Pump With Interoperable Technology |
| Applicant | Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego, CA 92121 |
| Contact | Michael Sarrasin |
| Product Code | QFG |
| Decision | Granted (DENG) |
| Review Advisory Board | Clinical Chemistry |
| Type | Direct |
| Date Received | 2018-10-29 |
| Decision Date | 2019-02-14 |
| Reclassification Order: | Reclassification Order |