The following data is part of a premarket notification filed by Tandem Diabetes Care, Inc. with the FDA for T:slim Insulin Delivery System, T:flex Insulin Delivery System, Tandem Device Updater.
| Device ID | K162080 |
| 510k Number | K162080 |
| Device Name: | T:slim Insulin Delivery System, T:flex Insulin Delivery System, Tandem Device Updater |
| Classification | Pump, Infusion, Insulin |
| Applicant | Tandem Diabetes Care, Inc. 11045 Roselle Street San Diego, CA 92121 |
| Contact | Michael Sarrasin |
| Correspondent | Michael Sarrasin Tandem Diabetes Care, Inc. 11045 Roselle Street San Diego, CA 92121 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-27 |
| Decision Date | 2016-10-25 |
| Summary: | summary |