The following data is part of a premarket notification filed by Insulet Corp. with the FDA for Ixl Diabetes Management System.
| Device ID | K031373 |
| 510k Number | K031373 |
| Device Name: | IXL DIABETES MANAGEMENT SYSTEM |
| Classification | Pump, Infusion, Insulin |
| Applicant | INSULET CORP. 100 CUMMINGS CENTER STE 239G Beverly, MA 01915 |
| Contact | A. Arthur Rankis |
| Correspondent | A. Arthur Rankis INSULET CORP. 100 CUMMINGS CENTER STE 239G Beverly, MA 01915 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-30 |
| Decision Date | 2003-12-19 |
| Summary: | summary |