Device Classification Name |
pump, infusion, insulin
|
510(k) Number |
K032257 |
Device Name |
MODEL IR 1200 INSULIN PUMP |
Applicant |
ANIMAS CORP. |
590 E. LANCASTER AVE. |
FRAZER,
PA
19355
|
|
Applicant Contact |
MICHAEL J ANDREWS |
Correspondent |
ANIMAS CORP. |
590 E. LANCASTER AVE. |
FRAZER,
PA
19355
|
|
Correspondent Contact |
MICHAEL J ANDREWS |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 07/22/2003 |
Decision Date | 10/16/2003 |
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
|
|
|