The following data is part of a premarket notification filed by Animas Corp. with the FDA for Ezmanager Max Diabetes Management Software.
| Device ID | K063674 |
| 510k Number | K063674 |
| Device Name: | EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE |
| Classification | Pump, Infusion, Insulin |
| Applicant | ANIMAS CORP. 200 LAWRENCE DR. West Chester, PA 19380 |
| Contact | Amy Smith |
| Correspondent | Amy Smith ANIMAS CORP. 200 LAWRENCE DR. West Chester, PA 19380 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-11 |
| Decision Date | 2007-03-30 |
| Summary: | summary |