The following data is part of a premarket notification filed by Insulet Corporation with the FDA for Omnipod Insulin Management System.
| Device ID | K160252 |
| 510k Number | K160252 |
| Device Name: | OmniPod Insulin Management System |
| Classification | Pump, Infusion, Insulin |
| Applicant | INSULET CORPORATION 600 TECHNOLOGY PARK DRIVE SUITE 200 Billerica, MA 01821 |
| Contact | Matthew King |
| Correspondent | Matthew King INSULET CORPORATION 600 TECHNOLOGY PARK DRIVE SUITE 200 Billerica, MA 01821 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-04-27 |
| Summary: | summary |