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 |