K160482 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 July 13, 2016, 142 days after receiving the submission on February 22, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K160482 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2016 |
| Decision Date | July 13, 2016 |
| Days to Decision | 142 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 |