Device Classification Name |
pump, infusion, insulin
|
510(k) Number |
K063674 |
Device Name |
EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE |
Applicant |
ANIMAS CORP. |
200 LAWRENCE DR. |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
AMY SMITH |
Correspondent |
ANIMAS CORP. |
200 LAWRENCE DR. |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
AMY SMITH |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 12/11/2006 |
Decision Date | 03/30/2007 |
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
|
|
|