Device Classification Name |
pump, infusion, insulin
|
510(k) Number |
K021439 |
Device Name |
MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO |
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 | 05/06/2002 |
Decision Date | 05/29/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|