Device Classification Name |
accessories, pump, infusion
|
510(k) Number |
K080587 |
Device Name |
EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE |
Applicant |
ANIMAS CORP. |
200 LAWRENCE DR. |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
JENNIFER BOSLEY |
Correspondent |
ANIMAS CORP. |
200 LAWRENCE DR. |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
JENNIFER BOSLEY |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 03/03/2008 |
Decision Date | 05/15/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|