The following data is part of a premarket notification filed by Insulet Corporation with the FDA for Omnipod Dash Insulin Management System.
| Device ID | K180045 |
| 510k Number | K180045 |
| Device Name: | Omnipod DASH 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 | 2018-01-08 |
| Decision Date | 2018-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10385082000009 | K180045 | 000 |
| 20385082000020 | K180045 | 000 |