The following data is part of a premarket notification filed by Insulet Corporation with the FDA for Omnipod Insulin Management System.
| Device ID | K131294 |
| 510k Number | K131294 |
| Device Name: | OMNIPOD INSULIN MANAGEMENT SYSTEM |
| Classification | Pump, Infusion, Insulin |
| Applicant | INSULET CORPORATION 9 OAK PARK DR. Bedford, MA 01730 |
| Contact | Tara N Turney |
| Correspondent | Tara N Turney INSULET CORPORATION 9 OAK PARK DR. Bedford, MA 01730 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2013-08-29 |
| Summary: | summary |