K162080 is an FDA 510(k) clearance for the t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).
Submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Cleared decision on October 25, 2016, 90 days after receiving the submission on July 27, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K162080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2016 |
| Decision Date | October 25, 2016 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LZG — Pump, Infusion, Insulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |