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 (with T:connect Mobile App).
| Device ID | K203234 |
| 510k Number | K203234 |
| Device Name: | T:slim X2 Insulin Pump With Interoperable Technology (with T:connect Mobile App) |
| Classification | Alternate Controller Enabled Insulin Infusion Pump |
| Applicant | Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego, CA 92121 |
| Contact | Ashley Reynolds |
| Correspondent | Ashley Reynolds Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego, CA 92121 |
| Product Code | QFG |
| CFR Regulation Number | 880.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-03 |
| Decision Date | 2022-02-15 |