K131294 is an FDA 510(k) clearance for the OMNIPOD INSULIN MANAGEMENT SYSTEM. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).
Submitted by Insulet Corporation (Bedford, US). The FDA issued a Cleared decision on August 29, 2013, 115 days after receiving the submission on May 6, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K131294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2013 |
| Decision Date | August 29, 2013 |
| Days to Decision | 115 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 |