K111210 is an FDA 510(k) clearance for the T:SLIM (TM) 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 November 9, 2011, 194 days after receiving the submission on April 29, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K111210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2011 |
| Decision Date | November 09, 2011 |
| Days to Decision | 194 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 |