K160056 is an FDA 510(k) clearance for the t:slim Insulin Delivery System. 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 25, 2016, 195 days after receiving the submission on January 12, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K160056 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2016 |
| Decision Date | July 25, 2016 |
| Days to Decision | 195 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 |