The following data is part of a premarket notification filed by Animas Corp. with the FDA for Ez Manager Max Diabetes Management Software.
| Device ID | K080587 |
| 510k Number | K080587 |
| Device Name: | EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE |
| Classification | Accessories, Pump, Infusion |
| Applicant | ANIMAS CORP. 200 LAWRENCE DR. West Chester, PA 19380 |
| Contact | Jennifer Bosley |
| Correspondent | Jennifer Bosley ANIMAS CORP. 200 LAWRENCE DR. West Chester, PA 19380 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-03 |
| Decision Date | 2008-05-15 |
| Summary: | summary |