The following data is part of a premarket notification filed by Insulet Corporation with the FDA for Omnipod Dash Insulin Management System With Interoperable Technology.
| Device ID | K191679 |
| 510k Number | K191679 |
| Device Name: | Omnipod DASH Insulin Management System With Interoperable Technology |
| Classification | Alternate Controller Enabled Insulin Infusion Pump |
| 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 | QFG |
| CFR Regulation Number | 880.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-24 |
| Decision Date | 2019-09-20 |
| Summary: | summary |