The following data is part of a premarket notification filed by Insulet Corporation with the FDA for Omnipod Insulin Management System, Omnipod Dash Insulin Management System.
| Device ID | K192659 |
| 510k Number | K192659 |
| Device Name: | Omnipod Insulin Management System, Omnipod DASH Insulin Management System |
| Classification | Pump, Infusion, Insulin |
| Applicant | Insulet Corporation 100 Nagog Park Acton, MA 01720 |
| Contact | Julie Perkins |
| Correspondent | Julie Perkins Insulet Corporation 100 Nagog Park Acton, MA 01720 |
| Product Code | LZG |
| Subsequent Product Code | NBW |
| Subsequent Product Code | NDC |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-25 |
| Decision Date | 2019-10-21 |
| Summary: | summary |